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

Vertex Pharmaceuticals Incorporated10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

VX-135DRUG

12 weeks of VX-135

ribavirinDRUG

12 weeks of ribavirin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (6)

California

La Jolla, California, United States

Florida

Orlando, Florida, United States

Georgia

Marietta, Georgia, United States

Tennessee

Germantown, Tennessee, United States

Outcomes

Primary Outcomes

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 Outcomes

The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)

Time frame: 16 weeks

The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)

Time frame: 24 weeks

The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)

Time frame: 36 weeks

The proportion of subjects who have virologic relapse

Time frame: 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

Time frame: Up to 64 weeks

The proportion of subjects who have virologic breakthrough

as measured by on-treatment HCV RNA values

Time frame: Up to 52 weeks

The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)

Time frame: up to 28 weeks

The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment

Time frame: Up to 60 weeks

Data from ClinicalTrials.gov

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