The primary objectives of this study are:* To determine the efficacy of GS-7977 + RBV with or without Peginterferon alfa-2a (PEG) as measured by the proportion of subjects with sustained viral response at 12 weeks after discontinuation of therapy (…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint is SVR12 (HCV RNA
discontinuation of therapy) in the Full Analysis Set (FAS) population.
The primary safety endpoint is any AE leading to permanent discontinuation of
study drug(s).
Secondary outcome
Secondary efficacy endpoints include the proportion of subjects with: HCV RNA <
LLOQ at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24); on
treatment virologic failure; and relapse.
Background summary
See protocol page 14, section 1.1
Study objective
The primary objectives of this study are:
* To determine the efficacy of GS-7977 + RBV with or without Peginterferon
alfa-2a (PEG) as measured by the proportion of subjects with sustained viral
response at 12 weeks after discontinuation of therapy (SVR12).
* To evaluate the safety and tolerability of GS-7977 + RBV with or without PEG
as assessed by review of the accumulated safety data.
The secondary objectives of this study are:
* To determine the proportion of subjects who attain SVR at 4 and 24 weeks
after discontinuation of therapy (SVR4 and SVR24)
* To evaluate the kinetics of plasma HCV RNA during and after treatment
discontinuation
* To evaluate the emergence of viral resistance to GS 7977 during and after
treatment discontinuation
The exploratory objectives of this study are:
* To assess the effect of treatment on quality of life
* To assess the association between insulin resistance and HCV infection
Study design
Open-labeled, multicenter study in subjects with chronic HCV infection and who
participated in a prior Gilead HCV study.
Approximately 600 subjects will be enrolled into one of the following treatment
arms:
* Arm 1 (genotype 2 HCV-infected subjects): GS-7977 400 mg QD + RBV (1000 or
1200 mg/day) for 12 weeks
* Arm 2 (genotype 2 and 3 HCV-infected subjects): GS-7977 400 mg QD + RBV (1000
or 1200 mg/day) for 24 weeks
* Arm 3 (all genotypes of HCV-infected subjects): GS-7977 400 mg QD + RBV (1000
or 1200 mg/day) + PEG (180 *g/week) for 12 weeks
HCV RNA results will be unblinded to the Investigator and Sponsor.
Subjects will be offered treatment based on prior treatment history, genotype,
interferon tolerance and other individual factors including investigator
judgment.
HCV RNA results will be unblinded to the Investigator and Sponsor.
Sequence Registry Study:
Subjects who do not achieve SVR will be eligible for enrollment in the Sequence
Registry Study. The purpose of the Sequence Registry Study will be to monitor
the persistence of resistant mutations for up to 3 years. The Sequence Registry
Study is described in a separate protocol (GS US 248 0123).
SVR Registry Study:
All subjects who achieve SVR will be eligible for enrollment in the SVR
Registry Study. The purpose of the SVR Registry Study will be to evaluate
durability of SVR for up to 3 years post-treatment. The SVR Registry Study is
described in a separate protocol (GS US-248-0122).
Intervention
* Arm 1 (genotype 2 HCV-infected subjects): GS-7977 400 mg QD + RBV (1000 or
1200 mg/day) for 12 weeks
* Arm 2 (genotype 2 and 3 HCV-infected subjects): GS-7977 400 mg QD + RBV (1000
or 1200 mg/day) for 24 weeks
* Arm 3 (all genotypes of HCV-infected subjects): GS-7977 400 mg QD + RBV (1000
or 1200 mg/day) + PEG (180 *g/week) for 12 weeks
Study burden and risks
For a complete overview of risks and discomforts related, please consult
Appendix 2.
Lakeside Drive 333
Foster City CA 94404
US
Lakeside Drive 333
Foster City CA 94404
US
Listed location countries
Age
Inclusion criteria
Subjects must meet the following eligibility criteria:
* Chronic HCV
* Subject must have participated in a prior Gilead HCV studie
* Eligibility for this study will be defined in the prior (parent) study with respect to prior treatment assignment, treatment outcome and completion of scheduled assessments. At a minimum, a subject must have completed all screening assessments and met all eligibility criteria in the parent study.
* If eligibility is not defined in the parent study, eligibility can be determined by the Medical Monitor on a case-by-case basis. The Medical Monitor will take into consideration the prior treatment assignment, treatment outcome and completion of scheduled assessments in the parent study.
* Agree to use two forms of contraception for the duration of the study and for 6 months after the last dose of study medication. Females of childbearing potential must have a negative pregnancy test at Screening and Baseline/Day 1
Exclusion criteria
Subjects will be ineligible if they meet any of the following criteria:
* Pregnant or nursing female or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day)
* Active substance abuse which, in the opinion of the investigator, would make the candidate inappropriate for participation in this study.
* Use of any prohibited concomitant medications within 28 days of the Baseline/Day 1 visit
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000571-16-NL |
| ClinicalTrials.gov | NCT01625338 |
| CCMO | NL41479.018.12 |