Trials / Completed
CompletedNCT01356160
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 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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 351 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GS-5885 | tablet, 30 mg QD |
| DRUG | GS-9451 | tablet, 200 mg QD |
| BIOLOGICAL | peginterferon alfa-2a | (solution for injection) 180 µg/week |
| DRUG | ribavirin tablet | ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) |
| DRUG | GS-9451 Placebo | Placebo to match GS-9451 QD |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2011-05-19
- Last updated
- 2014-02-03
Locations
23 sites across 3 countries: United States, Australia, Puerto Rico
Source: ClinicalTrials.gov record NCT01356160. Inclusion in this directory is not an endorsement.