Cirrhosis, LiverPhase 2NCT00244751
Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects
A Phase 2 study testing GI262570 0.5 mg and GI262570 1.0 mg in people with Cirrhosis, Liver, run by GlaxoSmithKline at 121 sites in 14 countries.
Trial summary
The purpose of this study is to examine the safety and effectiveness of GI262570 compared to placebo (a pill that looks exactly like GI262570 but contains no active medicine) in improving specific tests that indicate the degree of liver fibrosis (scarring). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- GI262570 0.5 mg and GI262570 1.0 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 121 sitesin 14 countries
- Study dates
- 2 Nov 2005to 13 Mar 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Age between 40 and 70 years, inclusive.
- Documented positive serology for HCV antibody by a second generation or higher assay.
- Serum HCV RNA positive and HCV viral Genotype 1 at pre-screening visit.
- Ishak fibrosis score of 2, 3 or 4.
- Failure to achieve sustained virologic response (SVR) with previous interferon (standard or pegylated) and ribavirin treatment administered at a minimum dose of 3mU three times weekly or equivalent, for at least 12 weeks. Reasons for failure may include failure to respond to treatment or intolerability to optimal treatment. Prior treatment with interferon/ribavirin must have been discontinued at least 11 months prior to the biopsy date.
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- Male or female; a female is eligible to enter and participate in this study if she is of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
- child-bearing potential, has a negative serum pregnancy test at screen, and agrees to one of the following:
- Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug, (a minimum of 5 half-lives or longer if the pharmacodynamic profile of the investigational drug warrants a longer time period); or,
- Female sterilization; or,
- Has a male partner who is sterilized; or,
- Implants of levonorgestrel; or,
- Injectable progestogen; or,
- Oral contraceptive (combined or progestogen only) , must be stable for 3 months prior to study entry; or,
- Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or,
- Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year; or,
- Barrier method only if used in combination with any of the above acceptable methods.
- Availability and willingness of subject to provide written informed consent.
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- History of ascites, variceal hemorrhage, hepatic encephalopathy, spontaneous bacterial peritonitis or other signs of hepatic decompensation.
- Current or historical evidence suggestive of ischemic heart disease or other cardiovascular disease that in the investigator's opinion may adversely impact the safety of the subject during the conduct of the study. Evidence suggestive of cardiovascular disease may come from a number of sources, including clinical history, physical exam, electrocardiogram, laboratory testing, and radiographic procedures.
- New York Heart Association (NYHA) Functional Class 1, 2, 3, or 4 cardiac status
- Co-infection with HBV or HIV.
- Liver histology consistent with any other co-existing cause of chronic liver disease.
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- Documented evidence of a hepatic mass lesion suspicious for hepatocellular carcinoma.
- Alpha-fetoprotein > 200ng/mL at pre-screening.
- Inadequate hematologic function defined by any of the following:
- Hemoglobin (<12.5 g/dL for men)(<12.0 g/dL for women)
- Absolute Neutrophil Count (ANC) (<1.0 x 10^9/L) Platelets (<130X/10^9/L)
- Inadequate renal function defined as:
- Serum creatinine (>1.5mg/dL (≥130mmol/L)) Calculated creatinine clearance as calculated by Cockcroft and Gault (<60mL/min)
- Serum ALT level ≥5 x ULN.
- Albumin <3.2g/dL.
- Total bilirubin >1.2 x ULN.
- Prothrombin time > 15 seconds or International normalized ratio (INR) > 1.3.
- Organ, stem cell, or bone marrow transplant.
- Serious concurrent medical illness that in the investigator's opinion might interfere with therapy. This includes significant systemic illnesses (other than liver disease) such as chronic pancreatitis.
- Active systemic autoimmune disorder.
- A pre-existing condition interfering with normal gastrointestinal anatomy or motility, and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
- Other medical conditions that, in the investigator's opinion, might interfere with compliance with therapy, participation in the study or interpretation of results.
- Pregnancy (or lactation) or, in subjects capable of bearing children, inability/unwillingness to practice adequate contraception.
- Females of child-bearing potential (post-puberty) unwilling or unable to have pregnancy testing at any study visit.
- Therapy with systemic cytotoxic agents, immunomodulators, or immunosuppressive therapy requiring use of more than 5mg of prednisone (or its equivalent) per day.
- Therapy with a systemic antiviral agent (with the exception of prophylaxis or treatment of influenza or chronic HSV) within the past 30 days.
- Concurrent participation in another clinical trial in which the subject is or will be exposed to another investigational or a non-investigational drug or device within 30 days of the screening visit.
- Current therapy or anticipated need for therapy with hypoglycemic drugs (e.g., insulin, sulfonylurea or metformin).
- Known hypersensitivity to GI262570, or to any component of the GI262570 soft gelatin capsules, dispersion tablets or the sodium salt tablet or to PPARg agonists.
- A history of hepatotoxicity to TZDs and/or a history of severe edema or medically serious fluid-related events associated with the use of TZDs.
- Use of other PPAR agonists (e.g., rosiglitazone, pioglitazone) within 1 year from the start of dosing.
- Active alcohol abuse within the past 1 year.
- Use of illegal drugs in the past 1 year. 30a. Macular edema or history of macular edema.
Trial locations and contacts
121 sites in 14 countries.
121 sites in 14 countries
United States58 sites
GSK Investigational Site
Ann Arbor, Michigan, 48109
GSK Investigational Site
Atlanta, Georgia, 30033
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Atlanta, Georgia, 30309
GSK Investigational Site
Bakersfield, California, 93301
GSK Investigational Site
Binghamton, New York, 13901
GSK Investigational Site
Birmingham, Alabama, 35294-0005
GSK Investigational Site
Boston, Massachusetts, 02111
GSK Investigational Site
Boston, Massachusetts, 02114
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Charlottesville, Virginia, 22908
GSK Investigational Site
Cincinnati, Ohio, 45219
GSK Investigational Site
Cincinnati, Ohio, 45267-0595
GSK Investigational Site
Cleveland, Ohio, 44195
GSK Investigational Site
Dallas, Texas, 75390-8887
GSK Investigational Site
Detroit, Michigan, 48202
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Englewood, Colorado, 80113
GSK Investigational Site
Fairfax, Virginia, 22031
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Hershey, Pennsylvania, 17033-0850
GSK Investigational Site
Honolulu, Hawaii, 96817
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
La Jolla, California, 92024
GSK Investigational Site
Lancaster, Pennsylvania, 17604-3200
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Los Angeles, California, 90095
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Lutherville-Timonium, Maryland, 21093
GSK Investigational Site
Manhasset, New York, 11030
GSK Investigational Site
Marietta, Georgia, 30060
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
New York, New York, 10003
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
New York, New York, 10029
GSK Investigational Site
New York, New York, 10032
GSK Investigational Site
Newport Beach, California, 92663
GSK Investigational Site
North Little Rock, Arkansas, 72117
GSK Investigational Site
Orlando, Florida, 32804
GSK Investigational Site
Pasadena, California, 91105
GSK Investigational Site
Richmond, Virginia, 23249
GSK Investigational Site
Richmond, Virginia, 23298
GSK Investigational Site
Sacramento, California, 95825
GSK Investigational Site
San Antonio, Texas, 78215
GSK Investigational Site
San Clemente, California, 92673
GSK Investigational Site
San Francisco, California, 94121
GSK Investigational Site
Santa Clara, California, 95051
GSK Investigational Site
Sarasota, Florida, 34243
GSK Investigational Site
St Louis, Missouri, 63104
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
The Bronx, New York, 10468
GSK Investigational Site
Tucson, Arizona, 85719
GSK Investigational Site
Tulsa, Oklahoma, 74104
GSK Investigational Site
Washington D.C., District of Columbia, 20010
GSK Investigational Site
Worcester, Massachusetts, 01655
Germany14 sites
GSK Investigational Site
Berlin, 13353
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53127
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40225
GSK Investigational Site
Erlangen, Bavaria, 91054
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Halle, Saxony-Anhalt, 06120
GSK Investigational Site
Hamburg, 20246
GSK Investigational Site
Hanover, Lower Saxony, 30625
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120
GSK Investigational Site
Homburg, Saarland, 66421
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Münster, North Rhine-Westphalia, 48149
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72076
Canada11 sites
GSK Investigational Site
Calgary, Alberta, T2N 4N1
GSK Investigational Site
Halifax, Nova Scotia, B3H 2Y9
GSK Investigational Site
London, Ontario, N6A 5A5
GSK Investigational Site
Montreal, Quebec, H2X 3J4
GSK Investigational Site
Ottawa, Ontario, K1H 8L6
GSK Investigational Site
Toronto, Ontario, M5G 1X5
GSK Investigational Site
Toronto, Ontario, M5G 2N2
GSK Investigational Site
Toronto, Ontario, M5T 2S8
GSK Investigational Site
Vancouver, British Columbia, V5Z 1H2
GSK Investigational Site
Victoria, British Columbia, V8V 3P9
GSK Investigational Site
Winnipeg, Manitoba, R3E 3P4
Australia6 sites
GSK Investigational Site
Camperdown, Victoria
GSK Investigational Site
Clayton, Victoria, 3168
GSK Investigational Site
Fitzroy, Melbourne, Victoria, 3065
GSK Investigational Site
Heidelberg, Victoria, 3084
GSK Investigational Site
Herston, Queensland, 4029
GSK Investigational Site
Melbourne, Victoria, 3004
Israel6 sites
GSK Investigational Site
Haifa, 31096
GSK Investigational Site
Jerusalem, 91120
GSK Investigational Site
Nazareth, 16100
GSK Investigational Site
Petah Tikva, 49100
GSK Investigational Site
Rehovot, 76100
GSK Investigational Site
Tel Aviv, 64239
Russia5 sites
GSK Investigational Site
Moscow, 105229
GSK Investigational Site
Moscow, 115516
GSK Investigational Site
Moscow, 121170
GSK Investigational Site
Moscow, 129110
GSK Investigational Site
Saint Petersburg
South Korea5 sites
GSK Investigational Site
Daegu, 700-721
GSK Investigational Site
Pusan, 602-739
GSK Investigational Site
Seoul, 135-710
GSK Investigational Site
Seoul, 138-736
GSK Investigational Site
Seoul, 150-713
Czechia4 sites
GSK Investigational Site
Brno-Bohunice, 625 00
GSK Investigational Site
Hradec Králové, 500 12
GSK Investigational Site
Prague, 140 21
GSK Investigational Site
Prague, 169 02
Taiwan4 sites
GSK Investigational Site
Kaohsiung City, 80708
GSK Investigational Site
Kaohsiung City, 833
GSK Investigational Site
Taipei, 112
GSK Investigational Site
Taoyuan, 333
Romania3 sites
GSK Investigational Site
Bucharest, 021105
GSK Investigational Site
Bucharest, 022328
GSK Investigational Site
Cluj-Napoca, Cluj, 400162
Malaysia2 sites
GSK Investigational Site
Bandar Tun Razak, Cheras, 59100
GSK Investigational Site
Kepong, 68100
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Multi-Center, Phase II Parallel Dose-Ranging Study to Assess the Antifibrotic Activity of GI262570 in Chronic Hepatitis C Subjects With Hepatic Fibrosis Who Have Failed Prior Antiviral Therapy
The purpose of this study is to examine the safety and effectiveness of GI262570 compared to placebo (a pill that looks exactly like GI262570 but contains no active medicine) in improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who are enrolled in the study must have had prior treatment with interferon (either pegylated or standard interferon) plus ribavirin for at least 12 weeks to treat their hepatitis C, but either failed to clear the virus or didn't tolerate the treatment.
- Conditions
- Cirrhosis, Liver
- Being tested
- GI262570 0.5 mg, GI262570 1.0 mg, Placebo
- Keywords
- Hepatitis C liver fibrosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI262570 0.5 mgDrug
GI262570 0.5 mg
GI262570 1.0 mgDrug
GI262570 1.0 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GI262570 0.5 mg | Experimental | Participants received GI262570 0.5 milligrams (mg) tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52. Receives: Drug: GI262570 0.5 mg |
| GI262570 1.0 mg | Experimental | Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52. Receives: Drug: GI262570 1.0 mg |
| Placebo | Placebo comparator | Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Liver Biopsy Immunohistochemical Marker of Hepatic Stellate Cell (HSC) Activation and Collagen Synthesis at Week 52
A percutaneous liver biopsy was obtained at the screening visit and at Week 52. A new liver biopsy at the screening visit was not taken in the event that a previous liver biopsy taken within 120 days of the Baseline /Day 1 visit (day of first dose), and the tissue block was available. The immunohistochemical marker assessed was smooth muscle alpha-actin (aSMA). Sections of the liver biopsies were stained by standard immunocytochemical techniques using a monoclonal antibody to smooth muscle actin with 'very intense purple' as the detection chromogen. This gives a reddish-purple color to the activated stellate cells, which strongly contrasts with the rest of the tissue. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing. The values are presented as proportion of positive area over total area.
Measured: Baseline and Week 52
Mean Change From Baseline in Fibrosis as Quantified by Morphometric Image Analysis
A percutaneous liver biopsy was obtained at the screening visit and at Week 52. A new liver biopsy at the screening visit was not taken in the event that a previous liver biopsy taken within 120 days of the Baseline /Day 1 visit (day of first dose), and the tissue block was available. Morphometric analysis was performed using specimens stained with Sirius red and computerized image analysis. Sirius red was used to stain extracellular collagen in liver sections. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing. The values are presented as proportion of positive area over total area.
Measured: Baseline and at Week 52
Number of Participants With Ranked Histological Assessment of the Paired Biopsies at Week 52
In ranked assessment (fibrosis and necroinflammation), available slides from each participant were evaluated as to whether one slide presents a globally more benign histopathology or whether the matched slides comprise globally equivalent histologic patterns. Subsequent data analysis revealed whether slides scored (within matched pairs of slides) as more benign occurred in different proportions of the Week 52 liver biopsies, according to treatment group. The number of participants with paired biopsies was based on the number with a Rank Assessment.
Measured: Week 52
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Measured: Up to 4 weeks post treatment (52 weeks)
Number of Participants With Abnormal ECG Findings
A standardized 12-lead ECGs were recorded at pre-screening, and pre-dose, at Baseline/Day 1, Weeks 16, 34, and 52 or withdrawal and at the 4 week follow-up visit. Any conditions such as bundle branch block, repolarization, depolarization, abnormal sinus rhythms, atrial fibrillation etc. are considered to be clinically abnormal findings.
Measured: Up to 4 weeks post-treatment (52 weeks)
Number of Participants With Change in Toxicities Grades 3 and 4 of Laboratory Parameters Over Time
Clinical laboratory parameters: Alkaline phosphatase, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Total bilirubin, Cholesterol, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Glucose, Hemoglobin, Potassium, Low density lipid (LDL) cholesterol, Lymphocytes, Sodium, Segmented neutrophils, Platelet count, White blood cell (WBC) count were assessed for change in grade toxicities. Toxicities were graded as grade 1 to grade 4 in increasing order of severity of toxicity. Thus grade 4 indicating severe toxicity. Only those parameters with grade 3 and 4 toxicities are presented.
Measured: Up to 4 weeks post-treatment (52 weeks)
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSP)
SBP and DBP readings were taken at pre-screening, pre-dose after 10 minutes of rest, at Baseline/Day 1, weeks 2, 4, 10, 16, 22, 28, 34, 40, 46, and 52 or WD and at the 4 week follow-up visit. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.
Measured: Baseline and up to 4 weeks post-treatment (52 weeks)
Mean Change From Baseline in Heart Rate
Heart rate assessment were done at pre-screening, pre-dose after 10 minutes of rest, at Baseline/Day 1, weeks 2, 4, 10, 16, 22, 28, 34, 40, 46, and 52 or WD and at the 4 week follow-up visit. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to be missing.
Measured: Baseline and up to 4 weeks post-treatment (52 weeks)
Number of Participants With Fluid Retention Events
Fluid retention event was one of the AEs reported. AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to 4 weeks post-treatment (52 weeks)
Secondary outcomes (19)
Number of Participants Progressing at Least 1 Point on the Ishak Fibrosis Score at Week 52
Progression was defined as an increase by at least one point in the fibrosis score. Score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The number of participants with paired biopsies is based on the number with an Ishak Fibrosis score.
Measured: Week 52
Number of Participants Regressing at Least 1 Point on the Ishak Fibrosis Score at Week 52
Regression was defined as a decrease by at least one point in the fibrosis score. Score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The number of participants with paired biopsies is based on the number with an Ishak Fibrosis score.
Measured: Week 52
Number of Participants Whose Ishak Fibrosis Score Remains Unchanged at Week 52
No change was defined as having the same score at both Baseline and at Week 52. Score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The number of participants with paired biopsies is based on the number with an Ishak Fibrosis score.
Measured: Week 52
Mean Change From Screening in Total Ishak Score (Necroinflammatory Score and Fibrosis Score) at Week 52
Ishak score ranged from 0 to 6 (higher score indicates greater fibrosis). 0: No fibrosis, 1: Fibrous expansion of some portal areas, with or without short fibrous septa, 2: Fibrous expansion of most portal areas, with or without short fibrous septa, 3: Fibrous expansion of most portal areas with portal to portal bridging, 4: Fibrous expansion of portal areas with marked bridging, 5: Marked bridging with occasional nodules (incomplete cirrhosis), 6: Cirrhosis, probable or definite. The necroinflammatory score is the combined score for necrosis and inflammation domains and ranged from 0 (best) to 14 (worst). Change from screening was calculated as the post screening assessment minus the screening assessment for a given parameter.
Measured: Screening and Week 52
Mean Change From Screening in Metavir Scores at Week 52
Metavir activity score ranged from 0 to 3 (higher score indicates severe symptoms of necrosis). 0: Piecemeal necrosis (PMN) absent and lobular necrosis (LN) absent or slight, 1: PMN slight and LN moderate, 2: PMN moderate and LN severe, 3: PMN severe. Metavir fibrosis score ranged from 0 to 4 (higher score indicates severe symptoms of necrosis). 0: No fibrosis, 1: Portal fibrosis without septa, 2: Portal fibrosis with septa, 3: Septal fibrosis without cirrhosis, 4: Cirrhosis. Change from screening was calculated as the post screening assessment minus the screening assessment for a given parameter.
Measured: Screening and Week 52
Mean Change From Baseline in Serum FibroSure (FibroTest/ActiTest) Score at Week 52
FibroTest was for the assessment of fibrosis. Fibro test was calculated using an original combination of five highly concentrated serum biochemical markers; alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin and gammaglutamyltransferase. FibroTest scores range from 0.00 to 1.00 where 0.0-0.21 is no fibrosis and >= 0.59 is cirrhosis. Acti-test was calculated using 6 serum biochemical markers; alpha2macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT and alanine aminotransferase. ActiTest was used for the assessment of necroinflammatory activity. Test score ranges from 0.00 to 1.00, where 0.00-0.17 indicates no necrosis and >= 0.61 indicates severe necrosis. Day 1 value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.
Measured: Baseline and Week 52
Mean Change From Baseline in Serum ALT Levels
ALT was assessed as per upper limit of normal where the normal range was 0-48 international units per liter. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.
Measured: Baseline and Week 52
Mean Change From Baseline in Measures of Insulin Resistance
Insulin resistance was measured using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), Belfiore Insulin Sensitivity Index (ISI) and Quantitative Insulin Sensitivity Check Index (QUICKI). HOMA-IR = fasting plasma insulin*fasting plasma glucose / 22.5 and ISI = 2 / [(fasting plasma glucose from the participant / fasting plasma glucose normal reference range)*( fasting plasma insulin from the participant / fasting plasma insulin normal reference range) + 1] and QUICKI = 1/(log[fasting plasma Insulin] + log[fasting plasma glucose]). Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.
Measured: Baseline and Week 52
Median Change From Baseline in Serum ALT Over Time
ALT was assessed as per upper limit of normal where the normal range was 0-48 international units per liter. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.
Measured: Baseline and up to 4 weeks post-treatment (52 weeks)
Mean Change From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 52
Value at Day 1 visit (day of first dose) was considered as Baseline. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.
Measured: Baseline and Week 52
Median Change From Baseline in Serum HCV RNA Levels Over Time
Serum for HCV RNA levels were collected at pre-screen, Baseline, Week 28, Week 52, and at the 4 week follow up visit. Value at Day 1 visit (day of first dose) was considered as Baseline. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.
Measured: Baseline and up to 4 weeks post-treatment (52 weeks)
Area Under the Plasma Concentration-time Curve During One Dosing Interval of Length 'Tau' (AUC [0-tau]) of GI262570 on Week 2
Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.
Measured: At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
Dose Normalized (DN) AUC (0-tau) of GI262570 on Week 2
Sample s for Week 2 serial group were collected at 0 (pre-morning dose )1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.
Measured: At 0 (pre-morning dose )1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
Apparent Clearance Following Oral Dosing (CL/F) of GI262570 on Week 2
Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.
Measured: At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
Maximum Observed Concentration (Cmax), Minimum Observed Concentration (Cmin) of GI262570 on Week 2
Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.
Measured: At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
DN Cmax of GI262570 on Week 2
Samples for Week 2 serial group were collected at 0 (pre-morning dose) 1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.
Measured: At 0 (pre-morning dose) 1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
Terminal Elimination Half-life (T1/2), Time to First Quantifiable Concentration (Tlag) and Time to Cmax (Tmax) of GI262570 on Week 2
Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.
Measured: At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
Volume of Distribution Expressed as a Function of Bioavailability (V/F) of GI262570
Samples for Week 2 serial group were collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. Initially the doses selected for the study were 0.5 mg twice daily and 1.0 mg twice daily. However, because of implementation of Amendment 4, the dose regimen was reduced to half the original dosing resulting in dose once daily.
Measured: At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
GI262570 Serum Concentrations on Week 2, 16, 28, 40, and Week 52
Samples for Week 2 serial group were planned to be collected at 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose. For Weeks 16 and 40 samples were planned to be collected at 0 (pre-morning dose)1 and between 1.5-6 hour post-morning dose 2. For Weeks 28 and 52 samples were planned to be collected at 0 (pre-morning dose)1 and between 6-10 hour post-morning dose 2.
Measured: Weeks 2, 16, 28, 40 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study start2 Nov 2005
- Primary completion13 Mar 2008
- Study completion13 Mar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244751
- Sponsor's protocol ID
- FBX104114
- Status last verified
- Nov 2017
- First submitted
- 25 Oct 2005
- Last updated
- 11 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Multi-Center, Phase II Parallel Dose-Ranging Study to Assess the Antifibrotic Activity of GI262570 in Chronic Hepatitis C Subjects With Hepatic Fibrosis Who Have Failed Prior Antiviral Therapy
- ClinicalTrials.gov ID
- NCT00244751
- Acronym / sponsor ID
- FBX104114
- Conditions
- Cirrhosis, Liver
- Keywords
- Hepatitis C liver fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2005 (actual)
- Primary completion
- 13 Mar 2008 (actual)
- Study completion
- 13 Mar 2008 (actual)
- First posted
- 27 Oct 2005 (estimated)
- Results
- Posted 11 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the safety and effectiveness of GI262570 compared to placebo (a pill that looks exactly like GI262570 but contains no active medicine) in improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who are enrolled in the study must have had prior treatment with interferon (either pegylated or standard interferon) plus ribavirin for at least 12 weeks to treat their hepatitis C, but either failed to clear the virus or didn't tolerate the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GI262570 0.5 mg | Experimental | Drug: GI262570 0.5 mgParticipants received GI262570 0.5 milligrams (mg) tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52. |
| GI262570 1.0 mg | Experimental | Drug: GI262570 1.0 mgParticipants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Age between 40 and 70 years, inclusive.
- Documented positive serology for HCV antibody by a second generation or higher assay.
- Serum HCV RNA positive and HCV viral Genotype 1 at pre-screening visit.
- Ishak fibrosis score of 2, 3 or 4.
Key exclusion criteria (33 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- History of ascites, variceal hemorrhage, hepatic encephalopathy, spontaneous bacterial peritonitis or other signs of hepatic decompensation.
- Current or historical evidence suggestive of ischemic heart disease or other cardiovascular disease that in the investigator's opinion may adversely impact the safety of the subject during the conduct of the study. Evidence suggestive of cardiovascular disease may come from a number of sources, including clinical history, physical exam, electrocardiogram, laboratory testing, and radiographic procedures.
- New York Heart Association (NYHA) Functional Class 1, 2, 3, or 4 cardiac status
- Co-infection with HBV or HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI262570 0.5 mgGI262570 0.5 mg | Drug | GI262570 0.5 mg |
| GI262570 1.0 mgGI262570 1.0 mg | Drug | GI262570 1.0 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Mean Change From Baseline in Liver Biopsy Immunohistochemical Marker of Hepatic Stellate Cell (HSC) Activation and Collagen Synthesis at Week 52
Time frame: Baseline and Week 52
A percutaneous liver biopsy was obtained at the screening visit and at Week 52. A new liver biopsy at the screening visit was not taken in the event that a previous liver biopsy taken within 120 days of the Baseline /Day 1 visit (day of first dose), and the tissue block was available. The immunohistochemical marker assessed was smooth muscle alpha-actin (aSMA). Sections of the liver biopsies were stained by standard immunocytochemical techniques using a monoclonal antibody to smooth muscle actin with 'very intense purple' as the detection chromogen. This gives a reddish-purple color to the activated stellate cells, which strongly contrasts with the rest of the tissue. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing. The values are presented as proportion of positive area over total area.
Mean Change From Baseline in Fibrosis as Quantified by Morphometric Image Analysis
Time frame: Baseline and at Week 52
A percutaneous liver biopsy was obtained at the screening visit and at Week 52. A new liver biopsy at the screening visit was not taken in the event that a previous liver biopsy taken within 120 days of the Baseline /Day 1 visit (day of first dose), and the tissue block was available. Morphometric analysis was performed using specimens stained with Sirius red and computerized image analysis. Sirius red was used to stain extracellular collagen in liver sections. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing. The values are presented as proportion of positive area over total area.
Number of Participants With Ranked Histological Assessment of the Paired Biopsies at Week 52
Time frame: Week 52
In ranked assessment (fibrosis and necroinflammation), available slides from each participant were evaluated as to whether one slide presents a globally more benign histopathology or whether the matched slides comprise globally equivalent histologic patterns. Subsequent data analysis revealed whether slides scored (within matched pairs of slides) as more benign occurred in different proportions of the Week 52 liver biopsies, according to treatment group. The number of participants with paired biopsies was based on the number with a Rank Assessment.
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 4 weeks post treatment (52 weeks)
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Number of Participants With Abnormal ECG Findings
Time frame: Up to 4 weeks post-treatment (52 weeks)
A standardized 12-lead ECGs were recorded at pre-screening, and pre-dose, at Baseline/Day 1, Weeks 16, 34, and 52 or withdrawal and at the 4 week follow-up visit. Any conditions such as bundle branch block, repolarization, depolarization, abnormal sinus rhythms, atrial fibrillation etc. are considered to be clinically abnormal findings.
Number of Participants With Change in Toxicities Grades 3 and 4 of Laboratory Parameters Over Time
Time frame: Up to 4 weeks post-treatment (52 weeks)
Clinical laboratory parameters: Alkaline phosphatase, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Total bilirubin, Cholesterol, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Glucose, Hemoglobin, Potassium, Low density lipid (LDL) cholesterol, Lymphocytes, Sodium, Segmented neutrophils, Platelet count, White blood cell (WBC) count were assessed for change in grade toxicities. Toxicities were graded as grade 1 to grade 4 in increasing order of severity of toxicity. Thus grade 4 indicating severe toxicity. Only those parameters with grade 3 and 4 toxicities are presented.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DSP)
Time frame: Baseline and up to 4 weeks post-treatment (52 weeks)
SBP and DBP readings were taken at pre-screening, pre-dose after 10 minutes of rest, at Baseline/Day 1, weeks 2, 4, 10, 16, 22, 28, 34, 40, 46, and 52 or WD and at the 4 week follow-up visit. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to missing.
Mean Change From Baseline in Heart Rate
Time frame: Baseline and up to 4 weeks post-treatment (52 weeks)
Heart rate assessment were done at pre-screening, pre-dose after 10 minutes of rest, at Baseline/Day 1, weeks 2, 4, 10, 16, 22, 28, 34, 40, 46, and 52 or WD and at the 4 week follow-up visit. Day 1 (before dosing) value was considered to be as Baseline value. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment for a given parameter. If either the Baseline or on-treatment value was missing, the change from Baseline value was also set to be missing.
Number of Participants With Fluid Retention Events
Time frame: Up to 4 weeks post-treatment (52 weeks)
Fluid retention event was one of the AEs reported. AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
19 secondary outcomes
Number of Participants Progressing at Least 1 Point on the Ishak Fibrosis Score at Week 52
Time frame: Week 52
Number of Participants Regressing at Least 1 Point on the Ishak Fibrosis Score at Week 52
Time frame: Week 52
Number of Participants Whose Ishak Fibrosis Score Remains Unchanged at Week 52
Time frame: Week 52
Mean Change From Screening in Total Ishak Score (Necroinflammatory Score and Fibrosis Score) at Week 52
Time frame: Screening and Week 52
Mean Change From Screening in Metavir Scores at Week 52
Time frame: Screening and Week 52
Mean Change From Baseline in Serum FibroSure (FibroTest/ActiTest) Score at Week 52
Time frame: Baseline and Week 52
Mean Change From Baseline in Serum ALT Levels
Time frame: Baseline and Week 52
Mean Change From Baseline in Measures of Insulin Resistance
Time frame: Baseline and Week 52
Median Change From Baseline in Serum ALT Over Time
Time frame: Baseline and up to 4 weeks post-treatment (52 weeks)
Mean Change From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 52
Time frame: Baseline and Week 52
Median Change From Baseline in Serum HCV RNA Levels Over Time
Time frame: Baseline and up to 4 weeks post-treatment (52 weeks)
Area Under the Plasma Concentration-time Curve During One Dosing Interval of Length 'Tau' (AUC [0-tau]) of GI262570 on Week 2
Time frame: At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
Dose Normalized (DN) AUC (0-tau) of GI262570 on Week 2
Time frame: At 0 (pre-morning dose )1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
Apparent Clearance Following Oral Dosing (CL/F) of GI262570 on Week 2
Time frame: At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
Maximum Observed Concentration (Cmax), Minimum Observed Concentration (Cmin) of GI262570 on Week 2
Time frame: At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
DN Cmax of GI262570 on Week 2
Time frame: At 0 (pre-morning dose) 1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
Terminal Elimination Half-life (T1/2), Time to First Quantifiable Concentration (Tlag) and Time to Cmax (Tmax) of GI262570 on Week 2
Time frame: At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
Volume of Distribution Expressed as a Function of Bioavailability (V/F) of GI262570
Time frame: At 0 (pre-morning dose)1, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hour post-morning dose on Week 2
GI262570 Serum Concentrations on Week 2, 16, 28, 40, and Week 52
Time frame: Weeks 2, 16, 28, 40 and 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
121 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GI262570 0.5 mg and GI262570 1.0 mg in people with Cirrhosis, Liver, run by GlaxoSmithKline at 121 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 121 sites in United States, Germany, Canada, Australia, Israel and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Liver Biopsy Immunohistochemical Marker of Hepatic Stellate Cell (HSC) Activation and Collagen Synthesis at Week 52 (time frame: Baseline and Week 52). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.