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

Overview

The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.

Full Title of Study: “A Randomized, Phase 2a, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 30, 2014

Detailed Description

Up to twenty (20) subjects with CHC GT1 infection will be randomized in a 1:1 ratio (with stratification by IL-28B genotype (CC versus non-CC)) to evaluate VX-135 low dose or high dose both given in combination with RBV for 12 weeks. Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day 1 through end of follow-up for virologic breakthrough or relapse.

Interventions

  • Drug: VX-135
    • 12 weeks of VX-135
  • Drug: Ribavirin
    • 12 weeks of ribavirin

Arms, Groups and Cohorts

  • Experimental: VX-135 low dose in combination with ribavirin
    • 12 weeks of VX-135 in combination with ribavirin
  • Experimental: VX-135 high dose in combination with ribavirin

Clinical Trial Outcome Measures

Primary Measures

  • Safety
    • Time Frame: Week 12
    • The safety and tolerability as assessed by evaluating adverse events and laboratory testing.

Secondary Measures

  • evidence of HCV RNA viral load reduction
    • Time Frame: 16 weeks
    • The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)

Participating in This Clinical Trial

Key Inclusion Criteria:

  • Subjects (male and female) must be between 18-60 years of age – Subjects must have Chronic Hepatitis C – Subjects must be treatment naive – 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 – Diagnosis of or suspected hepatocellular carcinoma

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alios Biopharma Inc.
  • Collaborator
    • Vertex Pharmaceuticals Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor

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