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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

This study is currently recruiting participants.
Verified April 2013 by Vertex Pharmaceuticals Incorporated
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01726946
First received: November 7, 2012
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis C
 Drug: VX-135
Drug: ribavirin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

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 [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who have virologic relapse [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The proportion of subjects who have virologic breakthrough [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    as measured by on-treatment HCV RNA values

  • The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC) [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
  • The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment [ Time Frame: Up to 60 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726946

Contacts
Contact: Central Contact Center 617-341-6777 medicalinfo@vrtx.com

Locations
United States, California
California Recruiting
La Jolla, California, United States
United States, Florida
Florida Recruiting
Orlando, Florida, United States
United States, Georgia
Georgia Recruiting
Marietta, Georgia, United States
United States, Tennessee
Tennessee Recruiting
Germantown, Tennessee, United States
United States, Texas
Texas Recruiting
Arlington, Texas, United States
Texas Recruiting
Houston, Texas, United States
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01726946     History of Changes
Other Study ID Numbers: VX12-135-101
Study First Received: November 7, 2012
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vertex Pharmaceuticals Incorporated:
Chronic Hepatitis C
HCV
CHC

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013