A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
NCT00630058 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-01-06
Summary
The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C.
Conditions
- Hepatitis C
Interventions
- DRUG
-
MP-424(H), PEG-IFN-a-2b, RBV
MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
- DRUG
-
MP-424 (L), PEG-IFN-a-2b, RBV
MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
collaborator INDUSTRY -
Tanabe Pharma Corporation
lead INDUSTRY
Principal Investigators
-
Fumitaka Suzuki, MD · Department of Hepatology, Toranomon Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2009-03-31
- Completion
- 2009-03-31
Countries
- Japan
Study Locations
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