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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

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 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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VX-135 low dose in combination with ribavirin<br>12 weeks 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 high dose in combination with ribavirin<br> | 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 |
| --- | --- | --- |
| Safety | The safety and tolerability as assessed by evaluating adverse events and laboratory testing. | Week 12 | 

Secondary Outcome Measures

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