Trials / Completed
CompletedNCT00535847
A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy
A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 117 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Telaprevir | Tablet |
| DRUG | Ribavirin | Tablet |
| DRUG | Pegylated interferon alfa 2a | Solution for Injection |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2010-02-01
- Completion
- 2010-02-01
- First posted
- 2007-09-26
- Last updated
- 2014-08-05
- Results posted
- 2011-07-25
Locations
62 sites across 8 countries: United States, Austria, Canada, France, Germany, Netherlands, Puerto Rico, United Kingdom
Source: ClinicalTrials.gov record NCT00535847. Inclusion in this directory is not an endorsement.