Trials / Completed
CompletedNCT00420784
A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)
A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 465 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Telaprevir | tablet |
| DRUG | Ribavirin | tablet |
| DRUG | Pegylated Interferon Alfa 2a | Solution for injection |
| DRUG | Matching Placebo | Tablet |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2008-12-01
- Completion
- 2009-04-01
- First posted
- 2007-01-11
- Last updated
- 2014-08-05
- Results posted
- 2011-07-21
Locations
53 sites across 5 countries: United States, Canada, Germany, Netherlands, Puerto Rico
Source: ClinicalTrials.gov record NCT00420784. Inclusion in this directory is not an endorsement.