Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy
Phase 3
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT00780910
- 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 patients with (Genotype 1) hepatitis C, who relapsed after previous treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
Inclusion Criteria
- Genotype 1, chronic hepatitis C
- Relapsers (patient who relapsed after previous treatment)
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MP-424 MP-424 - MP-424 Ribavirin - MP-424 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