Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)
Phase 3
Completed
- Conditions
- Chronic Hepatitis C(CHC)
- Interventions
- Registration Number
- NCT01753570
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
- Genotype 1 or 2, chronic hepatitis C, with depression(including the past)
- Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based 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 serious 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 RBV+IFN beta, Genotype1 IFN beta(48 weeks) - RBV+IFN beta, Genotype1 RBV(48 weeks) - MP-424+RBV+IFN beta, Genotype2 RBV(24 weeks) - MP-424+RBV+IFN beta, Genotype1 MP-424 - MP-424+RBV+IFN beta, Genotype1 IFN beta(24 weeks) - MP-424+RBV+IFN beta, Genotype1 RBV(24 weeks) - MP-424+RBV+IFN beta, Genotype2 IFN beta(24 weeks) - MP-424+RBV+IFN beta, Genotype2 MP-424 -
- Primary Outcome Measures
Name Time Method Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)
- Secondary Outcome Measures
Name Time Method Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) 4 weeks Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV. From baseline to 24 weeks after completion of drug administration To examine the emergence of resistance-associated variants after MP-424 administration.
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration 60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta) Transition of Serum HCV RNA Levels Baseline，Day2，Day3，1Week，2Weeks，3Weeks，4Weeks，12Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) 48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta)
Trial Locations
- Locations (1)
Toranomon Hospital
🇯🇵Kawasaki City, Takatsu-ku, Japan