Phase 2 Study of VX-950, Pegasys and Copegus in Hepatitis C

Phase 2

Completed

• Conditions: Hepatitis C

• Registration Number: NCT00262483
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with hepatitis C.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-02
• Study First Submitted QC: 2005-12-02
• Study First Posted: 2005-12-06
• Study Completion: 2006-04
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-17
• Last Update Posted: 2007-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Infected with hepatitis C virus

Exclusion Criteria

• Contraindications to peginterferon or ribavirin therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety of triple combination therapy.	retrospective and prospective

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of VX-950, peginterferon alfa-2a and ribavirin.	retrospective and prospective
Plasma HCV RNA levels	retrospective and prospective

Trial Locations

Locations (1)

Call for information; 🇵🇷 Santurce, Puerto Rico