Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy

April 16, 2014 updated by: Mitsubishi Tanabe Pharma Corporation

A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 1 Hepatitis C Who Relapsed After Previous Treatment

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in patients with (Genotype 1) hepatitis C, who relapsed after previous treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Takatsu-ku
      • Kawasaki City, Takatsu-ku, Japan
        • Toranomon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Genotype 1, chronic hepatitis C
  • 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MP-424
Drug: MP-424
750 mg every 8 hours for 12 weeks
Other Names:
  • Telaprevir
Drug: Ribavirin
600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b
1.5 mcg/kg/week for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
Time Frame: After 24 weeks of follow-up
After 24 weeks of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Collaborators

Vertex Pharmaceuticals Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

October 24, 2008

First Submitted That Met QC Criteria

October 26, 2008

First Posted (ESTIMATE)

October 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 2, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G060-A8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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