Hepatitis CPhase 2NCT01273064
Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders
A Phase 2 study testing CTS-1027, pegylated interferon and Ribavirin in people with Hepatitis C, run by Conatus Pharmaceuticals Inc. at 45 sites in United States.
Trial summary
Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC) treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1 chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- CTS-1027, pegylated interferon and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 45 sitesUnited States
- Study dates
- Jan 2011to Oct 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
- HCV genotype 1 infected null responders to prior therapy comprised of pegylated interferon and ribavirin (standard of care, SOC) defined as:
- Failure to achieve an early virologic response (< 2 log decline in HCV-RNA by Week 12), or
- If Week 12 HCV-RNA was not obtained, post Week 12 HCV-RNA response was < 2 log decline
- Screening HCV-RNA viral load of > 5.0 log (i.e., >100,000 IU/mL)
- alpha-fetoprotein (AFP) less than or equal to 100 ng/mL
Show all 10Show fewer
- Hemoglobin greater than or equal to 12 g/dL for women and greater than or equal to 13 g/dL for men, hemoglobin A1c less than or equal to 7.5 %, platelet count greater than or equal to 90 x 10^9/L, and white blood cell count greater than or equal to 1.5 x 10^9/L
- Thyroid Stimulating Hormone (TSH) within normal limits
- In the opinion of the Principal Investigator, the patient met the 80%/80%/80% rule during the previous pegylated interferon and ribavirin therapy (i.e., received at least 80% of the pegylated interferon and ribavirin doses, at least 80% of the dose size, for at least 80% of the treatment duration)
- Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to at least six months after the completion of the study.
Who cannot join
- < 2 log decline in HCV-RNA at Week 12 but > 2 log decline at any time from Week 12 to Week 24 during prior therapy with pegylated interferon and ribavirin (prior standard of care therapy)
- Decompensated or severe liver disease defined by one or more of the following criteria:
- Prothrombin time 4 seconds > control or INR (international normalized ratio) > 1.2
- Total bilirubin ≥ 1.5 mg/dL or direct bilirubin ≥ 1 mg/dL
- Serum albumin below normal limits
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 5 x upper limit of normal (ULN) at screening
Show all 30Show fewer
- Presence of ascites
- Hepatic encephalopathy
- Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
- Clinically significant ocular findings such as retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or other abnormality
- Known history or presence of human immunodeficiency virus (HIV) infection
- Co-infection with hepatitis B virus (HBV)
- If female: pregnant, lactating, or positive serum or urine pregnancy test
- Male partners of women who are currently pregnant
- Renal impairment (creatinine > 1.2 x ULN), serum creatinine clearance < 50 mL/min, or hepatorenal syndrome with ascites
- Hospitalization for liver disease within 60 days of screening
- History of alcohol abuse (> 50 g per day) within the past year
- History of severe psychiatric disease, especially depression, characterized by:
- Suicide attempt
- Hospitalization for psychiatric disease
- Period of disability as a result of psychiatric disease
- Prior exposure to CTS-1027
- Patients who qualify as a null-responder based on treatment(s) other than pegylated interferon and ribavirin
- History or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose corrected Q-T interval (QTc) of > 450 milliseconds
- History of or current autoimmune disease
- Diagnosis of or symptoms suggestive of fibromyalgia
- Currently on liver transplantation waiting list or recipient of any organ transplant
- Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
- Exposure to any other investigational treatment for any aspect of disease associated with HCV during the past 6 months
- Exposure to any investigational drug or device within 30 days of dosing, or scheduled receipt of another investigational drug or device during the course of this study.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Atlanta Medical Center, Inc.
Atlanta, Georgia, 30309
Liver Center of Atlanta
Atlanta, Georgia, 30309
University of Colorado Denver
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Rush University Medical Center
Chicago, Illinois, 60612
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Southern California Liver Centers
Coronado, California, 92118
Henry Ford Hospital
Detroit, Michigan, 48202-2689
Duke University Medical Center
Durham, North Carolina, 27710
Metropolitan Research Group Washington DC
Fairfax, Virginia, 22031
Baylor All Saints Medical Center
Fort Worth, Texas, 76104
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Research Specialists of Texas
Houston, Texas, 77030
St. Luke's Episcopal Hospital
Houston, Texas, 77030
University of Texas HSC at Houston
Houston, Texas, 77030
VAMC Houston
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46201
University of Kansas Medical Center
Kansas City, Kansas, 66160
Scripps Clinic
La Jolla, California, 92037
Loma Linda University MC
Loma Linda, California, 92354
University of Louisville
Louisville, Kentucky, 40202
Loyola University
Maywood, Illinois, 60153
University of Miami
Miami, Florida, 33136
Yale University School of Medicine
New Haven, Connecticut, 06520
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Concorde Medical Group
New York, New York, 10016
New York University
New York, New York, 10016
Weill Medical College of Cornell
New York, New York, 10021
Columbia Presbyterian Medical Center
New York, New York, 10032
Liver Institute of Virginia
Newport News, Virginia, 23602
Huntington Medical Research Institute
Pasadena, California, 91105
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Virginia Commonwealth University (VCU)
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84132
Medical Associates Research Group
San Diego, California, 92123
UCSD
San Diego, California, 92161
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101
St. Louis University
St Louis, Missouri, 63104
Einstein College of Medicine (Jacobi Medical Center)
The Bronx, New York, 10461
New York Medical College
Valhalla, New York, 10595
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of Pegylated Interferon Plus Ribavirin With or Without CTS-1027 in HCV Null-Responders
Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC) treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1 chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies).
Null-responders are defined as patients who failed to achieve a greater than 2 log drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as "viral load") levels after 12 weeks of treatment (know as an "early virologic response", or EVR) during previous SOC therapy.
Read more
If, during previous SOC treatment, a patient had a less than 2 log decline in HCV-RNA at Week 12 but greater than 2 log decline in HCV-RNA at any time from Week 12 to Week 24, that patient is not a null-responder, and is excluded from study participation. If, during previous SOC treatment, a Week 12 HCV-RNA was not obtained, the post Week 12 response must have been < 2 log decline (and still HCV-RNA positive) in order for the patient to be defined as a null-responder.
Patients will be screened and have up to 4 weeks to qualify for study entry. During this screening period, clinical and laboratory tests will be performed. At Week 0/Day 1, patients will undergo centralized, stratified (based on ethnicity), randomization to one of four treatment arms: SOC + one of three doses of CTS-1027 or SOC + placebo. Study treatment will last 24, 48, or 60 weeks, based on each patient's response to study treatment. SOC + placebo patients who do not show a virologic response after 12 weeks of therapy will be rolled onto SOC + 15mg CTS-1027, while maintaining the study blind.
Read the detailed description
Placebo controlled, double-blind, multicenter study utilizing Standard of Care (SOC) in combination with CTS-1027 in genotype 1 chronic hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies).
Null-responders are defined as patients who failed to achieve a greater than 2 log drop in HCV-RNA levels after 12 weeks of treatment (know as an early virologic response or EVR) during previous SOC therapy.
If, during previous SOC treatment, a patient had < 2 log decline in HCV-RNA at Week 12 but > 2 log decline in HCV-RNA at any time from Week 12 to Week 24, that patient is not a null-responder and is excluded from study participation. If, during previous SOC treatment, a Week 12 HCV-RNA was not obtained, the post Week 12 response must have been < 2 log decline (and still HCV-RNA positive) in order for the patient to be defined as a null-responder.
Patients will be screened and have up to 4 weeks to qualify for study entry. During this screening period, clinical and laboratory tests will be performed. At Week 0/Day 1, patients will undergo centralized, stratified (based on ethnicity), randomization to one of four treatment arms: SOC + one of three doses of CTS-1027 or SOC + placebo. Study treatment will last 24, 48, or 60 weeks, based on each patient's response to study treatment.
The Principal Investigators, other site personnel, and patients will be blinded to the HCV-RNA results for the first 12 weeks of therapy.
At Week 12, the study treatment blind will be broken by the study's Interactive Web Randomization System (IWRS). However, the Principal Investigators, other investigative site personnel, patients, and Sponsor will remain blinded to treatment allocation until Week 24 (see below). The patients on the SOC + placebo arm will continue treatment as follows:
- Patients on SOC + placebo who do not achieve at least a 2 log decline in their HCV-RNA at Week 12 will be automatically rolled-over into the SOC + 15 mg CTS-1027 twice a day (BID) arm. The treatment duration for these patients will be 60 weeks (i.e., 12 weeks on SOC + placebo, followed by 48 weeks on SOC + 15 mg BID).
- Those patients on SOC + placebo who achieve ≥ 2 log decline at Week 12 will continue on SOC therapy until Week 48.
Patients in the SOC + CTS-1027 arms will continue with the same treatment regimen for the initial 24 weeks regardless of HCV-RNA changes.
At Week 24, the study blind will be formally broken. Patients will continue the study as follows:
- Patients in the SOC + CTS-1027 arms who achieve ≥ 2 log HCV-RNA decline by Week 24 will continue with the same treatment regimen they were assigned during the Double-Blind Phase for an additional 24 weeks.
- Patients in the SOC + CTS-1027 15 mg BID and the SOC + CTS-1027 30 mg BID arms who achieve a <2 log HCV-RNA decline by Week 24 will escalate to the next higher dose of CTS-1027 for an additional 24 weeks.
- Patients in the SOC + CTS-1027 60 mg BID arm who do not achieve at least a 2 log HCV-RNA decline by Week 24 will be discontinued from the study.
All patients will be seen 4 and 12 weeks (Follow-Up Period) after the end of treatment. If a patient's HCV-RNA is undetectable at the end of treatment, he/she will be seen for an additional follow-up visit 24 weeks after the end of treatment.
- Conditions
- Hepatitis C
- Being tested
- CTS-1027, pegylated interferon, Ribavirin, Placebo
- Keywords
- HCV, Null Responders
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTS-1027Drug
Supplied in 30mg, 10mg, or 5mg tablets (depending on dose arm) taken twice daily for up to 48 weeks.
pegylated interferonDrug
Also called Pegasys
180 micrograms in 0.5 ml of solution subcutaneously (SQ), delivered in single use syringes administered once per week, for up to 48 weeks.
RibavirinDrug
Also called Copegus
200 mg capsules of ribavirn taken in two divided daily doses totaling 1000 mg (5 capsules) for patients weighing 75 kg or less, or 1200 mg (6 capsules) for patients weighing more than 75 kg
PlaceboDrug
Tablets identical in appearance to CTS-1027 containing inactive ingredients.
Placebo arm patients: Two tablets taken twice daily, for a total daily dose of four tablets.
30 mg CTS-1027 patients: One tablet taken twice daily, for a total daily dose of two tablets. One bottle of placebo is added to the 30mg kits in order to maintain the study blind (all patients recieve two-bottle kits of CTS-1027 and/or placebo).
| Study group | Role | What they receive |
|---|---|---|
| CTS-1027 60 mg + ribavirin + peglyated interferon | Experimental | Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027, 60 mg (supplied in a blinded kit containing two bottles of 30 mg tablets). One tablet from each of the CTS bottles is taken twice daily, for a total daily dose of 120 mg. Receives: Drug: CTS-1027; Drug: pegylated interferon; Drug: Ribavirin |
| CTS-1027 30 mg + ribavirin + pegylated interferon | Experimental | Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg, supplied in a blinded kit containing one bottle of 30 mg tablets, and one bottle of placebo tablets (in order to maintain blind). One tablet from each of the bottles is taken twice daily, for a total daily dose of 60 mg of CTS-1027. Receives: Drug: CTS-1027; Drug: pegylated interferon; Drug: Ribavirin; Drug: Placebo |
| CTS-1027 15 mg + ribavirin + pegylated interferon | Experimental | Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in a blinded kit containing one bottle each of of 5 mg and 10 mg tablets). One tablet from each of the CTS bottles is taken twice daily, for a total daily dose of 30 mg. Receives: Drug: CTS-1027; Drug: pegylated interferon; Drug: Ribavirin |
| placebo + ribavirin + pegylated interferon | Active comparator | Standard of Care (ribavirin plus pegylated interferon) plus placebo (supplied in a blinded kit containing two bottles of placebo tablets). One tablet is taken from each of the placebo bottles twice daily, for a total daily dose of 4 tablets. Receives: Drug: pegylated interferon; Drug: Ribavirin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response
Percent of patients that achieve a sustained virologic response (SVR) at Week 72 defined as HCV-RNA (Hepatitis C virus ribonucleic acid, also known as 'viral load') level below the quantification limit (BQL) at Week 72.
Measured: Baseline and 24 weeks after the end of treatment (Week 72)
Secondary outcomes (1)
Greater Than 2 Log Decline in HCV-RNA at Study Weeks 12, 24 and 48
Percent of patients experiencing a drop in Hepatitis C virus ribonucleic acid (HCV-RNA, also known as "viral load") levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 12, 24, and 48 weeks of treatment.
Measured: Baseline, and Study Weeks 12, 24, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionOct 2011
Why it stopped: Risk-benefit ratio
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 Hepatitis CStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Castelloe, MD, Study chair, Conatus Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273064
- Sponsor's protocol ID
- CTS-1027-05
- Status last verified
- Jun 2012
- First submitted
- 21 Dec 2010
- Last updated
- 11 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of Pegylated Interferon Plus Ribavirin With or Without CTS-1027 in HCV Null-Responders
- ClinicalTrials.gov ID
- NCT01273064
- Acronym / sponsor ID
- CTS-1027-05
- Conditions
- Hepatitis C
- Keywords
- HCV, Null Responders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Risk-benefit ratio
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Conatus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Posted 30 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC) treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1 chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies).
Null-responders are defined as patients who failed to achieve a greater than 2 log drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as "viral load") levels after 12 weeks of treatment (know as an "early virologic response", or EVR) during previous SOC therapy.
If, during previous SOC treatment, a patient had a less than 2 log decline in HCV-RNA at Week 12 but greater than 2 log decline in HCV-RNA at any time from Week 12 to Week 24, that patient is not a null-responder, and is excluded from study participation. If, during previous SOC treatment, a Week 12 HCV-RNA was not obtained, the post Week 12 response must have been < 2 log decline (and still HCV-RNA positive) in order for the patient to be defined as a null-responder.
Patients will be screened and have up to 4 weeks to qualify for study entry. During this screening period, clinical and laboratory tests will be performed. At Week 0/Day 1, patients will undergo centralized, stratified (based on ethnicity), randomization to one of four treatment arms: SOC + one of three doses of CTS-1027 or SOC + placebo. Study treatment will last 24, 48, or 60 weeks, based on each patient's response to study treatment. SOC + placebo patients who do not show a virologic response after 12 weeks of therapy will be rolled onto SOC + 15mg CTS-1027, while maintaining the study blind.
Detailed description
Placebo controlled, double-blind, multicenter study utilizing Standard of Care (SOC) in combination with CTS-1027 in genotype 1 chronic hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies).
Null-responders are defined as patients who failed to achieve a greater than 2 log drop in HCV-RNA levels after 12 weeks of treatment (know as an early virologic response or EVR) during previous SOC therapy.
If, during previous SOC treatment, a patient had < 2 log decline in HCV-RNA at Week 12 but > 2 log decline in HCV-RNA at any time from Week 12 to Week 24, that patient is not a null-responder and is excluded from study participation. If, during previous SOC treatment, a Week 12 HCV-RNA was not obtained, the post Week 12 response must have been < 2 log decline (and still HCV-RNA positive) in order for the patient to be defined as a null-responder.
Patients will be screened and have up to 4 weeks to qualify for study entry. During this screening period, clinical and laboratory tests will be performed. At Week 0/Day 1, patients will undergo centralized, stratified (based on ethnicity), randomization to one of four treatment arms: SOC + one of three doses of CTS-1027 or SOC + placebo. Study treatment will last 24, 48, or 60 weeks, based on each patient's response to study treatment.
The Principal Investigators, other site personnel, and patients will be blinded to the HCV-RNA results for the first 12 weeks of therapy.
At Week 12, the study treatment blind will be broken by the study's Interactive Web Randomization System (IWRS). However, the Principal Investigators, other investigative site personnel, patients, and Sponsor will remain blinded to treatment allocation until Week 24 (see below). The patients on the SOC + placebo arm will continue treatment as follows:
- Patients on SOC + placebo who do not achieve at least a 2 log decline in their HCV-RNA at Week 12 will be automatically rolled-over into the SOC + 15 mg CTS-1027 twice a day (BID) arm. The treatment duration for these patients will be 60 weeks (i.e., 12 weeks on SOC + placebo, followed by 48 weeks on SOC + 15 mg BID).
- Those patients on SOC + placebo who achieve ≥ 2 log decline at Week 12 will continue on SOC therapy until Week 48.
Patients in the SOC + CTS-1027 arms will continue with the same treatment regimen for the initial 24 weeks regardless of HCV-RNA changes.
At Week 24, the study blind will be formally broken. Patients will continue the study as follows:
- Patients in the SOC + CTS-1027 arms who achieve ≥ 2 log HCV-RNA decline by Week 24 will continue with the same treatment regimen they were assigned during the Double-Blind Phase for an additional 24 weeks.
- Patients in the SOC + CTS-1027 15 mg BID and the SOC + CTS-1027 30 mg BID arms who achieve a <2 log HCV-RNA decline by Week 24 will escalate to the next higher dose of CTS-1027 for an additional 24 weeks.
- Patients in the SOC + CTS-1027 60 mg BID arm who do not achieve at least a 2 log HCV-RNA decline by Week 24 will be discontinued from the study.
All patients will be seen 4 and 12 weeks (Follow-Up Period) after the end of treatment. If a patient's HCV-RNA is undetectable at the end of treatment, he/she will be seen for an additional follow-up visit 24 weeks after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CTS-1027 60 mg + ribavirin + peglyated interferon | Experimental | Drug: CTS-1027, Drug: pegylated interferon, Drug: RibavirinStandard of Care (ribavirin plus pegylated interferon) plus CTS-1027, 60 mg (supplied in a blinded kit containing two bottles of 30 mg tablets). One tablet from each of the CTS bottles is taken twice daily, for a total daily dose of 120 mg. |
| CTS-1027 30 mg + ribavirin + pegylated interferon | Experimental | Drug: CTS-1027, Drug: pegylated interferon, Drug: Ribavirin, Drug: PlaceboStandard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg, supplied in a blinded kit containing one bottle of 30 mg tablets, and one bottle of placebo tablets (in order to maintain blind). One tablet from each of the bottles is taken twice daily, for a total daily dose of 60 mg of CTS-1027. |
| CTS-1027 15 mg + ribavirin + pegylated interferon | Experimental | Drug: CTS-1027, Drug: pegylated interferon, Drug: RibavirinStandard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in a blinded kit containing one bottle each of of 5 mg and 10 mg tablets). One tablet from each of the CTS bottles is taken twice daily, for a total daily dose of 30 mg. |
| placebo + ribavirin + pegylated interferon | Active comparator | Drug: pegylated interferon, Drug: Ribavirin, Drug: PlaceboStandard of Care (ribavirin plus pegylated interferon) plus placebo (supplied in a blinded kit containing two bottles of placebo tablets). One tablet is taken from each of the placebo bottles twice daily, for a total daily dose of 4 tablets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
- HCV genotype 1 infected null responders to prior therapy comprised of pegylated interferon and ribavirin (standard of care, SOC) defined as:
- Screening HCV-RNA viral load of > 5.0 log (i.e., >100,000 IU/mL)
- alpha-fetoprotein (AFP) less than or equal to 100 ng/mL
- Hemoglobin greater than or equal to 12 g/dL for women and greater than or equal to 13 g/dL for men, hemoglobin A1c less than or equal to 7.5 %, platelet count greater than or equal to 90 x 10^9/L, and white blood cell count greater than or equal to 1.5 x 10^9/L
Key exclusion criteria (30 listed)
- < 2 log decline in HCV-RNA at Week 12 but > 2 log decline at any time from Week 12 to Week 24 during prior therapy with pegylated interferon and ribavirin (prior standard of care therapy)
- Decompensated or severe liver disease defined by one or more of the following criteria:
- Hepatic encephalopathy
- Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
- Clinically significant ocular findings such as retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or other abnormality
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 |
|---|---|---|
| CTS-1027Supplied in 30mg, 10mg, or 5mg tablets (depending on dose arm) taken twice daily for up to 48 weeks. | Drug | CTS-1027 15 mg + ribavirin + pegylated interferon, CTS-1027 30 mg + ribavirin + pegylated interferon, CTS-1027 60 mg + ribavirin + peglyated interferon |
| pegylated interferonAlso: Pegasys180 micrograms in 0.5 ml of solution subcutaneously (SQ), delivered in single use syringes administered once per week, for up to 48 weeks. | Drug | CTS-1027 15 mg + ribavirin + pegylated interferon, CTS-1027 30 mg + ribavirin + pegylated interferon, CTS-1027 60 mg + ribavirin + peglyated interferon, placebo + ribavirin + pegylated interferon |
| RibavirinAlso: Copegus200 mg capsules of ribavirn taken in two divided daily doses totaling 1000 mg (5 capsules) for patients weighing 75 kg or less, or 1200 mg (6 capsules) for patients weighing more than 75 kg | Drug | CTS-1027 15 mg + ribavirin + pegylated interferon, CTS-1027 30 mg + ribavirin + pegylated interferon, CTS-1027 60 mg + ribavirin + peglyated interferon, placebo + ribavirin + pegylated interferon |
| PlaceboTablets identical in appearance to CTS-1027 containing inactive ingredients. Placebo arm patients: Two tablets taken twice daily, for a total daily dose of four tablets. 30 mg CTS-1027 patients: One tablet taken twice daily, for a total daily dose of two tablets. One bottle of placebo is added to the 30mg kits in order to maintain the study blind (all patients recieve two-bottle kits of CTS-1027 and/or placebo). | Drug | CTS-1027 30 mg + ribavirin + pegylated interferon, placebo + ribavirin + pegylated interferon |
Primary outcome
Sustained Virologic Response
Time frame: Baseline and 24 weeks after the end of treatment (Week 72)
Percent of patients that achieve a sustained virologic response (SVR) at Week 72 defined as HCV-RNA (Hepatitis C virus ribonucleic acid, also known as 'viral load') level below the quantification limit (BQL) at Week 72.
1 secondary outcome
Greater Than 2 Log Decline in HCV-RNA at Study Weeks 12, 24 and 48
Time frame: Baseline, and Study Weeks 12, 24, and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- 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.
Erin Castelloe, MD study chair
Conatus Pharmaceuticals Inc.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTS-1027, pegylated interferon and Ribavirin in people with Hepatitis C, run by Conatus Pharmaceuticals Inc. at 45 sites in United States.
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 10 inclusion and 30 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: stopped early, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. 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. 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 30 May 2012). 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?
Sustained Virologic Response (time frame: Baseline and 24 weeks after the end of treatment (Week 72)). 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 Jun 2012.