Trials / Completed
CompletedNCT01353248
GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GS-5885 | tablet, 30 mg QD |
| DRUG | Tegobuvir | capsule, 30 mg BID |
| DRUG | GS-9451 | tablet, 200 mg QD |
| DRUG | ribavirin tablet | (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) |
| DRUG | GS-5885 | tablet, 90 mg QD |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2012-10-01
- Completion
- 2013-03-01
- First posted
- 2011-05-13
- Last updated
- 2013-12-20
Locations
43 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT01353248. Inclusion in this directory is not an endorsement.