A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: MP-424(H), PEG-IFN-a-2b, RBV; Drug: MP-424 (L), PEG-IFN-a-2b, RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT00630058

G060-A5

Details and patient eligibility

About

The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C.

Enrollment: 20 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with genotype 1b chronic hepatitis C

Exclusion criteria

• Patients diagnosed with decompensated cirrhosis
• Patients diagnosed with positive HBs antigen in the test

Trial design

20 participants in 2 patient groups

Group A (MP-424 High)

Experimental group

Treatment:

Drug: MP-424(H), PEG-IFN-a-2b, RBV

Group B (MP-424 Low)

Experimental group

Treatment:

Drug: MP-424 (L), PEG-IFN-a-2b, RBV