A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C - Tabular View

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A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C

This study is ongoing, but not recruiting participants.
Information provided by Vertex Pharmaceuticals Incorporated

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C

Official Title ^†

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

Brief Summary

The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with peginterferon alfa-2a (Pegasys®), and ribavirin (Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Undetectable HCV RNA [ Time Frame: 24 weeks after the completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Undetectable HCV RNA [ Time Frame: at end of treatment ] [ Designated as safety issue: No ]
Undetectable HCV RNA [ Time Frame: 48 weeks after completion of treatment (Groups B, C, and D) ] [ Designated as safety issue: No ]
Adverse events and clinical laboratory assessments, including ALT and other liver function tests. [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Genotypic and phenotypic analyses of the NS3•4A HCV region. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Pharmacokinetic assessments of telaprevir, Peg-IFN-a-2a, and RBV. [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Condition ^†

Hepatitis C

Intervention ^†

Drug: Telaprevir
Drug: Ribavirin
Drug: Peg-interferon Alfa-2a

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

440

Start Date ^†

January 2007

Completion Date

May 2009

Eligibility Criteria ^†

Inclusion Criteria:

Males and females between 18 and 70 years old
Detectable plasma HCV RNA > or = 10,000 IU/mL
Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin
Can not also be infected with HIV (AIDS) or hepatitis B
Must be judged to be in general good health and able to receive Pegasys® and Copegus®.
No drug or alcohol abuse in the last year
Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
If you are a woman, you can not be in this study if you are pregnant or nursing.

Exclusion Criteria:

Participation in any clinical trial of a HCV protease inhibitor of any duration.
Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis.
Diagnosed or suspected hepatocellular carcinoma.
History of or current evidence of decompensated liver disease.
Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada, Germany, Netherlands, Puerto Rico

Administrative Information Fields

NCT ID ^†

NCT00420784

Organization ID

VX06-950-106

Secondary IDs ^††

Study Sponsor ^†

Vertex Pharmaceuticals Incorporated

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Vertex Pharmaceuticals Incorporated

Information Provided By

Vertex Pharmaceuticals Incorporated

Verification Date

January 2008

First Received Date ^†

January 8, 2007

Last Updated Date

January 16, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.