Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
Phase 3
Completed
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT00780416
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 189
Inclusion Criteria
- Genotype 1, chronic hepatitis C
- Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C)
- Able and willing to follow contraception requirements
Exclusion Criteria
- Cirrhosis of the liver or hepatic failure
- Hepatitis B surface antigen-positive or HIV antibodies-positive
- History of, or concurrent hepatocellular carcinoma
- History of, or concurrent depression, schizophrenia; or suicide attempt in the past
- Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TRV/PEG/RBV Ribavirin - TRV/PEG/RBV Peginterferon Alfa-2b - PEG/RBV Ribavirin - TRV/PEG/RBV MP-424 - PEG/RBV Peginterferon Alfa-2b -
- Primary Outcome Measures
Name Time Method The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) After 24 weeks of follow-up
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Toranomon Hospital
🇯🇵Kawasaki City, Takatsu-ku, Japan