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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01790100

Enrollment

Registered

2013-02-13

Start date

2013-02-28

Completion date

2014-06-30

Last updated

2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

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.

Interventions

DRUGVX-135

12 weeks of VX-135

DRUGRibavirin

12 weeks of ribavirin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	Week 12	The safety and tolerability as assessed by evaluating adverse events and laboratory testing.

Secondary

Measure	Time frame	Description
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)

Countries

Moldova

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026