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

Phase 2

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: VX-135; Drug: ribavirin

• Registration Number: NCT01726946
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-15
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-03
• Disposition First Submitted: 2015-03-06
• Disposition First Submitted QC: 2015-03-27
• Last Update Submitted: 2015-03-27
• Disposition First Posted: 2015-04-16
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VX-135 High Dose with ribavirin	ribavirin	12 weeks of a high dose of VX-135 in combination with ribavirin
VX-135 High Dose with ribavirin	VX-135	12 weeks of a high dose of VX-135 in combination with ribavirin
VX-135 Low Dose with ribavirin	VX-135	12 weeks of a low dose of VX-135 in combination with ribavirin
VX-135 Low Dose with ribavirin	ribavirin	12 weeks of a low dose of VX-135 in combination with ribavirin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	Up to 52 weeks	as measured by on-treatment HCV RNA values
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

Trial Locations

Locations (5)

Florida; 🇺🇸 Orlando, Florida, United States

Texas; 🇺🇸 Houston, Texas, United States

Tennessee; 🇺🇸 Germantown, Tennessee, United States

Georgia; 🇺🇸 Marietta, Georgia, United States

California; 🇺🇸 La Jolla, California, United States