Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: Ribavirin; Drug: MP-424 (generic name:Telaprevir); Drug: Peginterferon alfa-2b

Study type: Interventional

Funder types: Industry

Identifiers

NCT01466192

G060-A10

Details and patient eligibility

About

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous treatment.

Enrollment: 108 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Genotype 2, 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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108 participants in 1 patient group

MP-424

Experimental group

Treatment:

Drug: Peginterferon alfa-2b

Drug: Ribavirin

Drug: MP-424 (generic name:Telaprevir)