VX-950 and Peginterferon for Hepatitis C

December 17, 2007 updated by: Vertex Pharmaceuticals Incorporated

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

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

Study Overview

Status

Completed

Conditions

Hepatitis C

Intervention / Treatment

Study Type

Interventional

Enrollment

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Homburg/Saar, Germany
    - Call For Information
Netherlands
- - Amsterdam, Netherlands
    - Call For Information

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

infected with Hepatitis C virus

Exclusion Criteria:

contraindications to peginterferon therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Viral kinetics

Secondary Outcome Measures

Outcome Measure
Assess the safety of VX-950 in combination with peginterferon

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (ACTUAL)

March 1, 2006

Study Registration Dates

First Submitted

November 7, 2005

First Submitted That Met QC Criteria

November 7, 2005

First Posted (ESTIMATE)

November 9, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 21, 2007

Last Update Submitted That Met QC Criteria

December 17, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

VX05-950-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.