VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C

July 2, 2014 updated by: Vertex Pharmaceuticals Incorporated

A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C

The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Anaheim, California, United States
      • Riverside, California, United States
      • San Diego, California, United States
    • Colorado
      • Englewood, Colorado, United States
    • Florida
      • Orlando, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
    • Maryland
      • Baltimore, Maryland, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinatti, Ohio, United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Norfolk, Virginia, 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 (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
  • Subjects will be treatment naïve
  • Subjects must have documentation of the presence or absence of cirrhosis

Exclusion Criteria:

  • History or other clinical evidence of significant or unstable cardiac disease
  • Evidence of hepatic decompensation
  • Diagnosed or suspected hepatocellular carcinoma
  • Any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
  • History of organ transplant, with the exception of corneal transplants and skin grafts

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12 week treatment
Drug: VX-222
400 mg tablets twice daily for oral administration
Drug: telaprevir
1125 mg tablets twice daily for oral administration
Other Names:
  • VX-950, INCIVEK, INCIVO, TELAVIC
Drug: ribavirin
1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
Other Names:
  • Copegus
Experimental: 16 week treatment
Drug: VX-222
400 mg tablets twice daily for oral administration
Drug: telaprevir
1125 mg tablets twice daily for oral administration
Other Names:
  • VX-950, INCIVEK, INCIVO, TELAVIC
Drug: ribavirin
1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed 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 viral response (SVR) at 12 weeks after the last planned dose of treatment
Time Frame: 12 weeks after the last planned dose of treatment
12 weeks after the last planned dose of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)
Time Frame: up to 20 weeks
up to 20 weeks
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug
Time Frame: 24 weeks after the last planned dose of the study drug
24 weeks after the last planned dose of the study drug
The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug
Time Frame: 4 weeks after the last planned dose of the study drug
4 weeks after the last planned dose of the study drug
The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT)
Time Frame: 48 weeks either after the last planned dose of study drug or after time of failure
48 weeks either after the last planned dose of study drug or after time of failure
The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT)
Time Frame: up to 16 weeks
up to 16 weeks
Time to achieve <LLOQ undetectable HCV RNA
Time Frame: up to 16 weeks
up to 16 weeks
The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT)
Time Frame: up to 16 weeks
up to 16 weeks
The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12
Time Frame: 12 weeks after the last planned dose of treatment
12 weeks after the last planned dose of treatment
The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure
Time Frame: 48 weeks either after the last planned dose of study drug or after time of failure
48 weeks either after the last planned dose of study drug or after time of failure

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

July 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

July 4, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX11-222-108

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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