Clinical Trials Directory

Trials / Completed

CompletedNCT00630058

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

A Phase I, Open-Label, Two-Arm Study of MP-424 in Combination With Peginterferon Alfa 2b and Ribavirin in Patients With Genotype 1b Hepatitis C

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Tanabe Pharma Corporation · Industry
Sex
All
Age
20 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGMP-424(H), PEG-IFN-a-2b, RBVMP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
DRUGMP-424 (L), PEG-IFN-a-2b, RBVMP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks

Timeline

Start date
2008-04-01
Primary completion
2009-03-01
Completion
2009-03-01
First posted
2008-03-06
Last updated
2026-01-06
Results posted
2013-01-18

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT00630058. Inclusion in this directory is not an endorsement.