Hepatitis C, ChronicPhase 2NCT01356160
GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus
A Phase 2 study testing GS-5885, GS-9451 and peginterferon alfa-2a in people with Hepatitis C, Chronic, run by Gilead Sciences at 23 sites in 3 countries.
Trial summary
This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- GS-5885, GS-9451 and peginterferon alfa-2a
- 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
- 351 participants
- Where
- 23 sitesin 3 countries
- Study dates
- Jul 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 (≤ 2 years prior to Screening) indicating the absence of cirrhosis.
- Monoinfection with HCV genotype 1
- HCV RNA > 10^4 IU/mL at Screening
- HCV treatment naïve
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- Candidate for PEG/RBV therapy
- Body mass index (BMI) 18-36 kg/m2, inclusive
- Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline.
Who cannot join
- Pregnant female or male with pregnant female partner
- Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH)
- 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 resolved 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. Patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included into the study.
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
United States21 sites
Study site
Arlington, Texas, 76012
Study site
Aurora, Colorado, 80045
Study site
Baltimore, Maryland, 21202
Study site
Baltimore, Maryland, 21229
Study site
Beverly Hills, California, 90211
Study site
Bradenton, Florida, 34209
Study site
Burlington, Massachusetts, 01805
Study site
Cincinnati, Ohio, 45267
Study site
Coronado, California, 92118
Study site
Costa Mesa, California, 92626
Study site
Durham, North Carolina, 27710
Study site
Englewood, Colorado, 80110
Study site
Fairfax, Virginia, 22031
Study site
Forest Hills, New York, 11375
Study site
Houston, Texas, 77030
Study site
Kansas City, Missouri, 64131
Study site
Manhasset, New York, 11030
Study site
Nashville, Tennessee, 37211
Study site
San Antonio, Texas, 78215
Study site
San Diego, California, 92123
Study site
Tucson, Arizona, 85724
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy With GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.
- Conditions
- Hepatitis C, Chronic
- Being tested
- GS-5885, GS-9451, peginterferon alfa-2a, ribavirin tablet, GS-9451 Placebo
- Keywords
- Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy HCV RNA, Protease inhibitor, Treatment naïve, GS-5885, GS-9451
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-5885Drug
tablet, 30 mg QD
GS-9451Drug
tablet, 200 mg QD
peginterferon alfa-2aBiological
(solution for injection) 180 µg/week
ribavirin tabletDrug
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
GS-9451 PlaceboDrug
Placebo to match GS-9451 QD
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV Receives: Drug: GS-5885; Drug: GS-9451; Biological: peginterferon alfa-2a; Drug: ribavirin tablet |
| Arm 2 | Placebo comparator | RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV Receives: Drug: GS-5885; Biological: peginterferon alfa-2a; Drug: ribavirin tablet; Drug: GS-9451 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the antiviral efficacy of response guided therapy.
To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA < Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.
Measured: Through 24 weeks post-treatment
Secondary outcomes (4)
To evaluate the safety and tolerability of each regimen.
The primary safety endpoint is any AE leading to permanent discontinuation of study drugs.
Measured: Through 24 weeks post-treatment
To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV.
HCV RNA levels, pharmacokinetics and viral sequencing
Measured: Through Day 10 on study
To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV.
Plasma samples will be collected and stored at each visit for possible resistance analysis.
Measured: 12 or 24 weeks
To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV.
Plasma concentrations of the study drug over time will be summarized using descriptive statistics.
Measured: Through 48 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startJul 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 Hepatitis C, ChronicStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bittoo Kanwar, MD, Study chair, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356160
- Sponsor's protocol ID
- GS-US-256-0148
- Status last verified
- Jan 2014
- First submitted
- 2 May 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 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy With GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT01356160
- Acronym / sponsor ID
- GS-US-256-0148
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy HCV RNA, Protease inhibitor, Treatment naïve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 May 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 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: GS-5885, Drug: GS-9451, Biological: peginterferon alfa-2a, Drug: ribavirin tabletRGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV |
| Arm 2 | Placebo comparator | Drug: GS-5885, Biological: peginterferon alfa-2a, Drug: ribavirin tablet, Drug: GS-9451 PlaceboRGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females 18-70 years of age
- Chronic HCV infection
- Subjects must have liver biopsy results (≤ 2 years prior to Screening) indicating the absence of cirrhosis.
- Monoinfection with HCV genotype 1
- HCV RNA > 10^4 IU/mL at Screening
Key exclusion criteria (4 listed)
- Pregnant female or male with pregnant female partner
- Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH)
- 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 resolved 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. Patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included into the study.
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-5885tablet, 30 mg QD | Drug | Arm 1, Arm 2 |
| GS-9451tablet, 200 mg QD | Drug | Arm 1 |
| peginterferon alfa-2a(solution for injection) 180 µg/week | Biological | Arm 1, Arm 2 |
| ribavirin tabletribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) | Drug | Arm 1, Arm 2 |
| GS-9451 PlaceboPlacebo to match GS-9451 QD | Drug | Arm 2 |
Primary outcome
To evaluate the antiviral efficacy of response guided therapy.
Time frame: Through 24 weeks post-treatment
To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA < Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.
4 secondary outcomes
To evaluate the safety and tolerability of each regimen.
Time frame: Through 24 weeks post-treatment
To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV.
Time frame: Through Day 10 on study
To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV.
Time frame: 12 or 24 weeks
To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV.
Time frame: Through 48 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Bittoo Kanwar, MD study chair
Gilead Sciences
23 sites in 3 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 peginterferon alfa-2a in people with Hepatitis C, Chronic, run by Gilead Sciences at 23 sites in 3 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 9 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: finished, 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 23 sites in United States, Australia, Puerto Rico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the antiviral efficacy of response guided therapy. (time frame: Through 24 weeks post-treatment). 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.