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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01516918
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : October 20, 2014
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Virus Drug: VX-222 Drug: telaprevir Drug: ribavirin Biological: peginterferon-alfa-2a Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
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.
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments. [ Time Frame: up to 48 weeks ]
  2. The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24) [ Time Frame: 24 weeks ]
  3. 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 ]
  4. 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 ]
  5. The association of the IL-28B genotype with SVR12 [ Time Frame: 12 weeks ]
    Proportion of subjects who have SVR12 by IL-28B genotype

  6. 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 ]
    The identity and observed frequency of viral variants as compared to wild-type virus will be measured.

  7. VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01516918

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Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
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Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated

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Responsible Party: Vertex Pharmaceuticals Incorporated Identifier: NCT01516918     History of Changes
Other Study ID Numbers: VX11-222-106
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs