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A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C
This study has been completed.
Study NCT00420784   Information provided by Vertex Pharmaceuticals Incorporated
First Received: January 8, 2007   Last Updated: May 8, 2009   History of Changes

January 8, 2007
May 8, 2009
January 2007
April 2009   (final data collection date for primary outcome measure)
Undetectable HCV RNA [ Time Frame: 24 weeks after the completion of treatment ] [ Designated as safety issue: No ]
Undetectable HCV RNA 24 weeks after the completion of treatment.
Complete list of historical versions of study NCT00420784 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Undetectable HCV RNA at end of treatment.
  • Undetectable HCV RNA 48 weeks after completion of treatment (Groups B, C, and D).
  • Adverse events and clinical laboratory assessments, including ALT and other liver function tests.
  • Genotypic and phenotypic analyses of the NS3•4A HCV region.
  • Pharmacokinetic assessments of telaprevir, Peg-IFN-a-2a, and RBV.
 
A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C
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

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.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Hepatitis C
  • Drug: Telaprevir
  • Drug: Ribavirin
  • Drug: Peg-interferon Alfa-2a
  • Placebo Comparator: Placebo + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks
  • Experimental: Telaprevir + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks
  • Experimental: Telaprevir + Peg-IFN for 24 weeks
  • Experimental: Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 12 weeks
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
440
April 2009
April 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Netherlands,   Puerto Rico
 
NCT00420784
Robert Kauffman M.D., Ph.D., Vertex Pharmaceuticals Incorporated
VX06-950-106
Vertex Pharmaceuticals Incorporated
 
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP