A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01516918
First received: January 13, 2012
Last updated: April 7, 2014
Last verified: April 2014

January 13, 2012
April 7, 2014
February 2012
September 2013   (final data collection date for primary outcome measure)
The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01516918 on ClinicalTrials.gov Archive Site
  • The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: Yes ]
  • The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment [ Time Frame: up to week 12 ] [ Designated as safety issue: No ]
  • The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • The association of the IL-28B genotype with SVR12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects who have SVR12 by IL-28B genotype
  • The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure [ Time Frame: After the last planned dose of study drug or after time of failure ] [ Designated as safety issue: No ]
    The identity and observed frequency of viral variants as compared to wild-type virus will be measured.
  • VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis
A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis

The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C Virus
  • Drug: VX-222
    tablet, 400-mg twice daily
  • Drug: telaprevir
    tablet, 1125-mg twice daily
    Other Name: Incivek, VX-950, Incivo
  • Drug: ribavirin
    tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily
    Other Name: Copegus
  • Biological: peginterferon-alfa-2a
    subcutaneous injection, 180-mcg, once weekly
    Other Name: Pegasys
Experimental: Quadruple Regimen
All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks.
Interventions:
  • Drug: VX-222
  • Drug: telaprevir
  • Drug: ribavirin
  • Biological: peginterferon-alfa-2a
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
December 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have genotype 1 Chronic Hepatitis C
  • Subjects must have compensated cirrhosis
  • Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
  • Subjects with hemophilia may be permitted to enroll with permission of the medical monitor

Exclusion Criteria:

  • Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
  • Any contraindication to Peg-IFN or RBV therapy
  • Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
  • A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Poland,   United Kingdom
 
NCT01516918
VX11-222-106
Yes
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Not Provided
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
April 2014

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