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

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00420784
First received: January 8, 2007
Last updated: June 22, 2011
Last verified: June 2011

January 8, 2007
June 22, 2011
February 2007
December 2008   (final data collection date for primary outcome measure)
Undetectable HCV RNA at 24 Weeks After the Completion of Treatment [ Time Frame: 24 weeks after the end of treatment (after actual last dose) ] [ Designated as safety issue: No ]
The primary efficacy variable was the proportion of subjects with SVR, i.e., subjects with undetectable HCV RNA 24 weeks after the end of treatment (after actual last dose).
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 the completion of treatment ] [ Designated as safety issue: No ]
    Proportion of subjects with an end of treatment response [undetectable HCV RNA at end of treatment])
  • Undetectable HCV RNA [ Time Frame: 48 weeks after completion of treatment ] [ Designated as safety issue: No ]
    Proportion of Subjects with Undetectable HCV RNA at 24 Weeks AVFU for Treatment Groups Pbo/PR48,and at 48 Weeks AVFU for Treatment Groups T12/PR24, T24/PR48 and T24/P24
  • 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: Week 24 ] [ 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.
Not Provided
Not Provided
 
A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C
A Phase 2 Study of Telaprevir in Combination With Peginterferon Alfa-2a, and Ribavirin 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatitis C
  • Drug: Telaprevir
    tablet
    Other Name: VX-950
  • Drug: Ribavirin
    tablet
    Other Name: RBV
  • Drug: Peg-interferon Alfa-2a
    Solution for injection
    Other Name: Peg-IFN
  • Drug: Matching Placebo
    Tablet
  • Experimental: T12/PR24
    Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 12 weeks
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Drug: Peg-interferon Alfa-2a
  • Experimental: T24/PR48
    Telaprevir + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Drug: Peg-interferon Alfa-2a
  • Experimental: T24/P24
    Telaprevir + Peg-IFN for 24 weeks
    Interventions:
    • Drug: Telaprevir
    • Drug: Peg-interferon Alfa-2a
  • Placebo Comparator: Pbo24/PR48
    Placebo + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks
    Interventions:
    • Drug: Ribavirin
    • Drug: Peg-interferon Alfa-2a
    • Drug: Matching Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
465
April 2009
December 2008   (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
VX06-950-106
Yes
Robert Kauffman M.D., Ph.D., Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Not Provided
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
June 2011

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