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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00780416

G060-A6

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 treatment-naïve patients with (Genotype 1) hepatitis C.

Enrollment: 189 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Genotype 1, chronic hepatitis C
• Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C)
• 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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189 participants in 2 patient groups

TRV/PEG/RBV

Experimental group

Treatment:

Drug: Peginterferon Alfa-2b

Drug: Ribavirin

Drug: Ribavirin

Drug: MP-424

Drug: Peginterferon Alfa-2b

PEG/RBV

Active Comparator group

Treatment:

Drug: Peginterferon Alfa-2b

Drug: Ribavirin

Drug: Ribavirin

Drug: Peginterferon Alfa-2b