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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VX-135
ribavirin
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic Hepatitis C, HCV, CHC

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California
  • Florida
  • Georgia
  • Tennessee
  • Texas
  • Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

VX-135 High Dose with ribavirin

VX-135 Low Dose with ribavirin

Arm Description

12 weeks of a high dose of VX-135 in combination with ribavirin

12 weeks of a low dose of VX-135 in combination with ribavirin

Outcomes

Primary Outcome Measures

The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2012
Last Updated
March 27, 2015
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01726946
Brief Title
A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic Hepatitis C, HCV, CHC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VX-135 High Dose with ribavirin
Arm Type
Experimental
Arm Description
12 weeks of a high dose of VX-135 in combination with ribavirin
Arm Title
VX-135 Low Dose with ribavirin
Arm Type
Experimental
Arm Description
12 weeks of a low dose of VX-135 in combination with ribavirin
Intervention Type
Drug
Intervention Name(s)
VX-135
Intervention Description
12 weeks of VX-135
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
12 weeks of ribavirin
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
Time Frame
16 weeks
Title
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Time Frame
24 weeks
Title
The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)
Time Frame
36 weeks
Title
The proportion of subjects who have virologic relapse
Time Frame
Up to 52 weeks
Title
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
Title
The proportion of subjects who have virologic breakthrough
Description
as measured by on-treatment HCV RNA values
Time Frame
Up to 52 weeks
Title
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Time Frame
up to 28 weeks
Title
The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment
Time Frame
Up to 60 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
California
City
La Jolla
State/Province
California
Country
United States
Facility Name
Florida
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Georgia
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Tennessee
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
Texas
City
Arlington
State/Province
Texas
Country
United States
Facility Name
Texas
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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