Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C

Phase 2

Completed

• Conditions: Hepatitis C
• Interventions: Drug: MP-424 (Telaprevir)

• Registration Number: NCT00621296
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The purpose of this study is to assess the efficacy and safety after administration of MP-424 to patients with chronic hepatitis C.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-22
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2012-09-19
• Results First Submitted QC: 2012-09-19
• Results First Posted: 2012-10-19
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients diagnosed with genotype 1b chronic hepatitis C
• Patients naive to the concomitant medications with interferon

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MP-424	MP-424 (Telaprevir)	-

Primary Outcome Measures

Name	Time	Method
Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration	24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.

Trial Locations

Locations (1)

Toranomon Hospital; 🇯🇵 Kawasaki City, Takatsu-ku, Japan