VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
NCT01581138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2014-07-04
Summary
The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
Conditions
- Chronic Hepatitis C Virus
Interventions
- DRUG
-
VX-222
400 mg tablets twice daily for oral administration
- DRUG
-
telaprevir
1125 mg tablets twice daily for oral administration
- DRUG
-
ribavirin
1000 mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Vertex Pharmaceuticals Incorporated
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2013-06-30
- Completion
- 2013-12-31
Countries
- United States
Study Locations
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