Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: Ribavirin; Drug: MP-424; Drug: Peginterferon Alfa-2b

Study type: Interventional

Funder types: Industry

Identifiers

NCT00780910

G060-A8

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

MP-424

Experimental group

Treatment:

Drug: Peginterferon Alfa-2b

Drug: MP-424

Drug: Ribavirin