Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C (CHC)

Treatments: Drug: PEG-IFN alfa-2a; Drug: RBV; Drug: MP-424

Study type: Interventional

Funder types: Industry

Identifiers

NCT01753557

G060-A12

Details and patient eligibility

About

This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.

Enrollment: 54 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Genotype 1 CHC
• treatment-naïve or 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 (Human Immunodeficiency Virus) 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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54 participants in 2 patient groups

Treatment-Naive

Experimental group

Treatment:

Drug: MP-424

Drug: RBV

Drug: PEG-IFN alfa-2a

Treatment-Relapsed

Experimental group

Treatment:

Drug: MP-424

Drug: RBV

Drug: PEG-IFN alfa-2a