Chronic Hepatitis CPhase 2NCT01384383
GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
A Phase 2 study testing GS-5885, GS-9451 and RBV in people with Chronic Hepatitis C, run by Gilead Sciences at 55 sites in 4 countries.
Trial summary
This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- GS-5885, GS-9451 and RBV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 55 sitesin 4 countries
- Study dates
- Aug 2011to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 18-70 years of age
- Chronic HCV infection
- Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months of Screening in countries where allowed
- Monoinfection with HCV genotype 1a or 1b
- HCV RNA > 10^4 IU/mL at Screening
- IL28B CC genotype
Show all 11Show fewer
- HCV treatment naïve
- Candidate for PEG/RBV therapy
- Body mass index (BMI) between 18 and 36 kg/m2
- Creatinine clearance >= 50 mL/min
- Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline
Who cannot join
- Exceed defined thresholds for key laboratory parameters at Screening
- Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed
- Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study
- Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment
Trial locations and contacts
55 sites in 4 countries.
55 sites in 4 countries
United States26 sites
The North Texas Research Institute
Arlington, Texas, 76012
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, 28801
Commonwealth Clinical Studies, LLC
Brockton, Massachusetts, 02302
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Duke University
Durham, North Carolina, 27710
South Denver Gastroenterology
Englewood, Colorado, 80113
Metropolitan Liver Diseases Center
Fairfax, Virginia, 22031
North Shore University Hospital
Great Neck, New York, 11021
Research Specialists of Texas
Houston, Texas, 77030
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237
Impact Clinical Trials
Las Vegas, Nevada, 89106
Axis Clinical Trials
Los Angeles, California, 90036
Axis Clinical Trials
Los Angeles, California, 90057
UCLA Medical Center
Los Angeles, California, 90057
V.A. Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Weill Cornell College of Medicine
New York, New York, 10021
Liver Institute of Virginia, Bon Secours Health System
Newport News, Virginia, 23602
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Oregon Health & Science University
Portland, Oregon, 97239
UC Davis Medical Center
Sacramento, California, 95817
University of Utah Pediatric Pulmonology
Salt Lake City, Utah, 84143
Research and Education, Inc.
San Diego, California, 92105
San Jose Gastroenterology
San Jose, California, 95116
Harborview Medical Center
Seattle, Washington, 98104
Stanford University
Stanford, California, 94035
Westchester Medical Center
Yonkers, New York, 10701
Australia20 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Concord Repatriation General Hospital
Concord, New South Wales, 2137
Saint Vincents Hospital
Darlinghurst, New South Wales, 2010
St. Vincent's Hospital, Sydney Ltd.
Fitzroy, Victoria, 3065
Western Hospital
Footscray, Victoria, VIC 3011
Fremantle Hospital
Fremantle, Western Australia, 6160
Austin Health, Department of Hepatology
Heidelberg, Victoria, 3081
Royal Brisbane Hospital Research Foundation
Herston, Queensland, 4029
Nepean Hospital
Kingswood, New South Wales, 2747
St. George Hospital
Kogarah, New South Wales, NSW 2217
Alfred Hospital
Melbourne, Victoria, 3004
Monash Medical Centre
Melbourne, Victoria, 3004
Box Hill Hospital
Melbourne, Victoria, 3128
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal Melbourne Hospital
Parkville, Victoria, 3050
Liverpool Hospital
Sydney, New South Wales, 1871
Westmead Hospital
Westmead, New South Wales, 2145
Greenslopes Private Hospital
Woolloongabba, Queensland, 4102
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Canada7 sites
University of Calgary
Calgary, Alberta, T2N4N1
University of Alberta
Edmonton, Alberta, T6G 2C8
London Health Sciences
London, Ontario, N6A5A5
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
LAIR Centre
Vancouver, British Columbia, V5Z 1H2
GIRI GI Research Institute
Vancouver, British Columbia, V6Z 2K5
University of Manitoba, John Buhler Research Centre
Winnipeg, Manitoba, R3E 3P4
New Zealand2 sites
Auckland Hospital
Aukland
Waikato Hospital
Hamilton, 3240
About this study
Official title: A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 With Peginterferon Alfa 2a and Ribavirin (RBV) in Treatment-Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype
This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.
- Conditions
- Chronic Hepatitis C
- Being tested
- GS-5885, GS-9451, RBV, PEG
- Keywords
- Chronic Hepatitis C, IL28B CC Genotype, Treatment naive, Peginterferon α-2a (PEG), Genotype 1a/b, GS 9451, GS 5885, Ribavirin (RBV), HCV NS5A inhibitor, HCV NS3 protease inhibitor
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-5885Drug
GS-5885 30 mg tablet administered orally once daily
GS-9451Drug
GS-9451 200 mg tablet administered orally once daily
RBVDrug
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
PEGDrug
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks. Receives: Drug: GS-5885; Drug: GS-9451; Drug: RBV; Drug: PEG |
| Arm 2 | Experimental | Response-Guided Therapy with PEG and RBV for 24 weeks. Receives: Drug: RBV; Drug: PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response (SVR)
Sustained virologic response (SVR, defined as plasma HCV RNA < lower limit of quantification [LLoQ] at 24 weeks after treatment cessation) following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 or 12 weeks, or PEG/RBV for 24 weeks in IL28B CC subjects.
Measured: 30 , 36 or 48 weeks
Secondary outcomes (4)
Safety and tolerability of therapy
Safety and tolerability of the therapy is measured by frequency of laboratory abnormalities , reported adverse events and discontinuations due to adverse events.
Measured: Up to 48 weeks
Virologic response
Virologic response at Weeks 2, 4, 6, 8, 10, and 12 (depending on treatment arm) as measured by the rates of HCV RNA < LLoQ and viral breakthrough and relapse
Measured: Weeks 2, 4, 6, 8, 10, and 12
Compare SVR
Compare SVR following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 weeks versus 12 weeks.
Measured: Weeks 30 and 36
Viral resistance
Characterize viral resistance to GS-5885 and GS-9451 when administered in combination with PEG/RBV
Measured: Up to 96 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384383
- Sponsor's protocol ID
- GS-US-248-0121
- Status last verified
- Jan 2014
- First submitted
- 22 Jun 2011
- Last updated
- 3 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 With Peginterferon Alfa 2a and Ribavirin (RBV) in Treatment-Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype
- ClinicalTrials.gov ID
- NCT01384383
- Acronym / sponsor ID
- GS-US-248-0121
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic Hepatitis C, IL28B CC Genotype, Treatment naive, Peginterferon α-2a (PEG), Genotype 1a/b, GS 9451, GS 5885, Ribavirin (RBV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: GS-5885, Drug: GS-9451, Drug: RBV, Drug: PEGResponse-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks. |
| Arm 2 | Experimental | Drug: RBV, Drug: PEGResponse-Guided Therapy with PEG and RBV for 24 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and females 18-70 years of age
- Chronic HCV infection
- Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months of Screening in countries where allowed
- Monoinfection with HCV genotype 1a or 1b
- HCV RNA > 10^4 IU/mL at Screening
Key exclusion criteria (4 listed)
- Exceed defined thresholds for key laboratory parameters at Screening
- Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed
- Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study
- Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment
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 |
|---|---|---|
| GS-5885GS-5885 30 mg tablet administered orally once daily | Drug | Arm 1 |
| GS-9451GS-9451 200 mg tablet administered orally once daily | Drug | Arm 1 |
| RBVRibavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) | Drug | Arm 1, Arm 2 |
| PEGPegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection | Drug | Arm 1, Arm 2 |
Primary outcome
Sustained virologic response (SVR)
Time frame: 30 , 36 or 48 weeks
Sustained virologic response (SVR, defined as plasma HCV RNA < lower limit of quantification [LLoQ] at 24 weeks after treatment cessation) following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 or 12 weeks, or PEG/RBV for 24 weeks in IL28B CC subjects.
4 secondary outcomes
Safety and tolerability of therapy
Time frame: Up to 48 weeks
Virologic response
Time frame: Weeks 2, 4, 6, 8, 10, and 12
Compare SVR
Time frame: Weeks 30 and 36
Viral resistance
Time frame: Up to 96 Weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
55 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GS-5885, GS-9451 and RBV in people with Chronic Hepatitis C, run by Gilead Sciences at 55 sites in 4 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 11 inclusion and 4 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 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Australia, Canada, New Zealand. 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?
The study was stopped early. Results are not available in the source record.
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 (SVR) (time frame: 30 , 36 or 48 weeks). 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 3 Feb 2014.