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

October 9, 2014 updated by: Vertex Pharmaceuticals Incorporated

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • London, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Germany
      • Hamburg, Germany
      • Heidelberg, Germany
      • Hessen, Germany
      • Koeln, Germany
      • Saschen, Germany
      • Stuttgart, Germany
  • Poland
      • Bialystok, Poland
      • Myslowice, Poland
      • Wroclaw, Poland
  • United Kingdom
      • London, United Kingdom
      • Plymouth, United Kingdom
      • Scotland, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • San Diego, California, United States
    • Colorado
      • Englewood, Colorado, United States
    • Florida
      • Bradenton, Florida, United States
      • Jacksonville, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Egg Harbor Township, New Jersey, United States
    • New York
      • Manhasset, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Tennessee
      • Germantown, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Biological: peginterferon-alfa-2a
subcutaneous injection, 180-mcg, once weekly
Other Names:
  • Pegasys
Drug: VX-222
tablet, 400-mg twice daily
Drug: telaprevir
tablet, 1125-mg twice daily
Other Names:
  • 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 Names:
  • Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.
Time Frame: up to 48 weeks
up to 48 weeks
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)
Time Frame: 24 weeks
24 weeks
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
up to week 12
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
up to 48 weeks
The association of the IL-28B genotype with SVR12
Time Frame: 12 weeks
Proportion of subjects who have SVR12 by IL-28B genotype
12 weeks
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.
After the last planned dose of study drug or after time of failure
VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX11-222-106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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