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

Phase 2

Completed

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

• Registration Number: NCT01790100
• Lead Sponsor: Alios Biopharma Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Study Start: 2013-02-28
• Primary Completion: 2014-06-30
• Study Completion: 2014-06-30
• Status Verified: 2017-12
• Disposition First Submitted: 2017-12-14
• Disposition First Submitted QC: 2017-12-14
• Last Update Submitted: 2017-12-14
• Disposition First Posted: 2017-12-18
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VX-135 high dose in combination with ribavirin	VX-135	-
VX-135 low dose in combination with ribavirin	VX-135	12 weeks of VX-135 in combination with ribavirin
VX-135 low dose in combination with ribavirin	Ribavirin	12 weeks of VX-135 in combination with ribavirin
VX-135 high dose in combination with ribavirin	Ribavirin	-

Primary Outcome Measures

Name	Time	Method
Safety	Week 12	The safety and tolerability as assessed by evaluating adverse events and laboratory testing.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Arensia, Republican Clinical Hospital; 🇲🇩 Chisinau, Moldova, Republic of