Overview

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

Status:
Completed

Trial end date:
2010-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Mitsubishi Tanabe Pharma Corporation

Collaborator:

Vertex Pharmaceuticals Incorporated

Treatments:

Interferon-alpha
Peginterferon alfa-2b
Ribavirin

Criteria

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