NCT01753570

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)

A Phase 3 Study of MP-424 in Combination With IFN Beta and RBV, in Subjects With Genotype 1/2 Hepatitis C, Who Are Treatment-Naïve or Have Received Interferon Based Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C(CHC)

Interventions

Type	Name	Description
DRUG	MP-424	MP-424: 750mg every 8 hours (q8h) for 12 weeks
DRUG	RBV(24 weeks)	RBV: 600 - 1000mg/day based on body weight for 24 weeks
DRUG	IFN beta(24 weeks)	IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks
DRUG	RBV(48 weeks)	RBV: 600 - 1000mg/day based on body weight for 48 weeks
DRUG	IFN beta(48 weeks)	IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-12-20
• Last updated: 2026-01-06
• Results posted: 2018-10-26

Locations

1 site across 1 country: Japan