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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

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ClinicalTrials.gov Identifier: NCT01726946
Recruitment Status : Completed
First Posted : November 15, 2012
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: VX-135 Drug: ribavirin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2012
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4) [ Time Frame: 16 weeks ]
  2. The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12) [ Time Frame: 24 weeks ]
  3. The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24) [ Time Frame: 36 weeks ]
  4. The proportion of subjects who have virologic relapse [ Time Frame: Up to 52 weeks ]
  5. 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 ]
  6. The proportion of subjects who have virologic breakthrough [ Time Frame: Up to 52 weeks ]
    as measured by on-treatment HCV RNA values

  7. The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC) [ Time Frame: up to 28 weeks ]
  8. The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment [ Time Frame: Up to 60 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726946


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

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01726946     History of Changes
Other Study ID Numbers: VX12-135-101
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: March 2015

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

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