A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C

March 27, 2015 updated by: Vertex Pharmaceuticals Incorporated

A Phase 2, Multicenter, Dose-Ranging Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C

A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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
    • California
      • La Jolla, California, United States
        • California
    • Florida
      • Orlando, Florida, United States
        • Florida
    • Georgia
      • Marietta, Georgia, United States
        • Georgia
    • Tennessee
      • Germantown, Tennessee, United States
        • Tennessee
    • Texas
      • Arlington, Texas, United States
        • Texas
      • Houston, Texas, United States
        • Texas

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Subjects (male and female) must be between the ages of 18 and 60 years at screening
  • Subjects must have genotype 1 Chronic Hepatitis C
  • Subjects must be treatment naïve
  • Subjects must have laboratory values at screening within limits as specified by the protocol

Key Exclusion Criteria:

  • Evidence of cirrhosis
  • Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
  • Any other cause of significant liver disease in addition to hepatitis C
  • Human immunodeficiency virus -1 or -2
  • Diagnosis of or suspected hepatocellular carcinoma
  • 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: VX-135 High Dose with ribavirin
12 weeks of a high dose of VX-135 in combination with ribavirin
Drug: VX-135
12 weeks of VX-135
Drug: ribavirin
12 weeks of ribavirin
EXPERIMENTAL: VX-135 Low Dose with ribavirin
12 weeks of a low dose of VX-135 in combination with ribavirin
Drug: VX-135
12 weeks of VX-135
Drug: ribavirin
12 weeks of ribavirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments
Time Frame: Up to 52 weeks
Up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
Time Frame: 16 weeks
16 weeks
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Time Frame: 24 weeks
24 weeks
The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)
Time Frame: 36 weeks
36 weeks
The proportion of subjects who have virologic relapse
Time Frame: Up to 52 weeks
Up to 52 weeks
Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -<LLOQ HCV RNA
Time Frame: Up to 64 weeks
Up to 64 weeks
The proportion of subjects who have virologic breakthrough
Time Frame: Up to 52 weeks
as measured by on-treatment HCV RNA values
Up to 52 weeks
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Time Frame: up to 28 weeks
up to 28 weeks
The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment
Time Frame: Up to 60 weeks
Up to 60 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

November 1, 2012

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (ESTIMATE)

November 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 16, 2015

Last Update Submitted That Met QC Criteria

March 27, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX12-135-101

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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