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NCT00251199 Clinical Trial

VX-950 and Peginterferon for Hepatitis C

Hepatitis C Clinical Trial

Official title:
A Phase 1b Viral Kinetic Study of VX-950 and Peginterferon in Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00251199
Other study ID # VX05-950-103
Secondary ID
Status Completed
Phase Phase 1
First received November 7, 2005
Last updated December 17, 2007
Start date October 2005
Est. completion date March 2006

Study information
Verified date December 2007
Source Vertex Pharmaceuticals Incorporated
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

VX-950 is an investigational drug , which is being tested in combination with a known treatment for hepatitis C, peginterferon.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- infected with Hepatitis C virus

Exclusion Criteria:

- contraindications to peginterferon therapy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• VX-950

• peginterferon

Locations
Country Name City State
Germany Call for information Homburg/Saar
Netherlands Call for information Amsterdam

Sponsors (1)
Lead Sponsor Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Viral kinetics
Secondary Assess the safety of VX-950 in combination with peginterferon
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