NCT00780416

Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Treatment-Naïve Subjects With Genotype 1 Hepatitis C

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	MP-424	750 mg every 8 hours for 12 weeks
DRUG	Ribavirin	600 - 1000 mg/day based on body weight for 24 weeks
DRUG	Peginterferon Alfa-2b	1.5 mcg/kg/week for 24 weeks
DRUG	Ribavirin	600 - 1000 mg/day based on body weight for 48 weeks
DRUG	Peginterferon Alfa-2b	1.5 mcg/kg/week for 48 weeks

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-10-27
• Last updated: 2026-01-06
• Results posted: 2012-08-20

Locations

1 site across 1 country: Japan