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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: VX-135
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VX-135 High Dose with ribavirin<br>12 weeks of a high dose of VX-135 in combination with ribavirin | Drug: VX-135<br>* 12 weeks of VX-135<br>Drug: ribavirin<br>* 12 weeks of ribavirin<br>|
| Experimental: VX-135 Low Dose with ribavirin<br>12 weeks of a low dose of VX-135 in combination with ribavirin | Drug: VX-135<br>* 12 weeks of VX-135<br>Drug: ribavirin<br>* 12 weeks of ribavirin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 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) |  | 16 weeks | 
| The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12) |  | 24 weeks | 
| The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24) |  | 36 weeks | 
| The proportion of subjects who have virologic relapse |  | 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 |  | Up to 64 weeks | 
| The proportion of subjects who have virologic breakthrough | 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) |  | up to 28 weeks | 
| The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment |  | Up to 60 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis C, HCV, CHC