Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00372385
First received: September 1, 2006
Last updated: June 22, 2011
Last verified: June 2011

September 1, 2006
June 22, 2011
August 2006
May 2008   (final data collection date for primary outcome measure)
Proportion of Subjects in Each Group With Undetectable Plasma HCV RNA, 24 Weeks After the Completion of the Assigned Study Drug Regimen [ Time Frame: 24 weeks after the completion of the assigned study drug regimen ] [ Designated as safety issue: No ]
Plasma HCV RNA 24 weeks post-treatment
Complete list of historical versions of study NCT00372385 on ClinicalTrials.gov Archive Site
  • Proportion of Subjects in Each Group With Undetectable Plasma HCV RNA, 12 Weeks After the Completion of the Assigned Study Drug Regimen [ Time Frame: 12 weeks after the completion of the assigned study drug regimen ] [ Designated as safety issue: No ]
  • Proportion of Subjects in Each of the Dose Groups B, C and D Who Received VX-950 With Undetectable Plasma HCV RNA at the Completion of the Study Drug Regimen [ Time Frame: Week 12, Week 24, Week 48 ] [ Designated as safety issue: No ]
  • Adverse Events and Clinical Laboratory Assessments, Including ALT and Other Liver Function Tests [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Genotypic and Phenotypic Analyses of the NS3•4A HCV Region [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Pharmacokinetic Assessments of Telaprevir, Peginterferon Alfa-2a, and Ribavirin [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Plasma HCV RNA at other timepoints
  • Safety Assessment
  • Analysis of viral variants
  • VX-950, Peg-IFN-a-2a, and RBV pharmacokinetics
Not Provided
Not Provided
 
Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C
A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With and Without Ribavirin (Copegus®) in Subjects With Hepatitis C

Compare the effectiveness of VX-950 in combination with Peg-Interferon alpha (Peg-IFN) with and without Ribavirin (RBV) in reducing plasma HCV RNA levels.

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
Chronic Hepatitis C
  • Drug: Ribavirin
    tablet
    Other Name: RBV
  • Drug: Peginterferon Alfa 2a
    Solution for injection
    Other Name: Peg-IFN
  • Drug: Placebo
    tablet
  • Drug: Telaprevir
    tablet
    Other Name: VX-950
  • Placebo Comparator: Pbo12/PR48
    Placebo + Peg-IFN + RBV for 12 weeks, followed by Peg-IFN and RBV for 36 weeks
    Interventions:
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa 2a
    • Drug: Placebo
  • Experimental: T12/PR24
    Telaprevir + Peg-IFN + RBV for 12 weeks followed by Peg-IFN + RBV for 12 weeks
    Interventions:
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa 2a
    • Drug: Telaprevir
  • Experimental: T12/PR12
    Telaprevir + Peg-IFN + RBV for 12 weeks
    Interventions:
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa 2a
    • Drug: Telaprevir
  • Experimental: T12/P12
    Telaprevir + Peg-IFN for 12 weeks
    Interventions:
    • Drug: Peginterferon Alfa 2a
    • Drug: Telaprevir
Hézode C, Forestier N, Dusheiko G, Ferenci P, Pol S, Goeser T, Bronowicki JP, Bourlière M, Gharakhanian S, Bengtsson L, McNair L, George S, Kieffer T, Kwong A, Kauffman RS, Alam J, Pawlotsky JM, Zeuzem S; PROVE2 Study Team. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med. 2009 Apr 30;360(18):1839-50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
334
June 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hepatitis C virus Genotype 1 with detectable plasma HCV RNA
  • Have been infected with Hepatitis C virus for >6 months
  • Seronegative for HbsAg and HIV1 and HIV2
  • Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
  • Female subjects must have a negative pregnancy test at all visits before the first dose.

Exclusion Criteria:

  • Received any approved or investigational drug or drug regimen for the treatment of hepatitis C.
  • Any medical contraindications to Peg-IFN-a-2a or RBV therapy
  • 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 (NASH) or primary biliary cirrhosis.
  • Diagnosed or suspected hepatocellular carcinoma.
  • Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before Study start.
  • Alcohol/drug abuse or excessive use in the last 12 months.
  • Participation in any investigational drug study 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 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   United Kingdom
 
NCT00372385
VX05-950-104EU
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