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
NCT01790100 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2017-12-18
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.
Conditions
- Chronic Hepatitis C
Interventions
- DRUG
-
VX-135
12 weeks of VX-135
- DRUG
-
Ribavirin
12 weeks of ribavirin
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
collaborator INDUSTRY -
Alios Biopharma Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2014-06-30
- Completion
- 2014-06-30
Countries
- Moldova
Study Locations
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