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

April 16, 2014 updated by: Mitsubishi Tanabe Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

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:

  • Patients diagnosed with genotype 1b chronic hepatitis C

Exclusion Criteria:

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

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (MP-424 High)
Drug: MP-424(H), PEG-IFN-a-2b, RBV
MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
Other Names:
  • Telaprevir
Experimental: Group B (MP-424 Low)
Drug: MP-424 (L), PEG-IFN-a-2b, RBV
MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
Other Names:
  • Telaprevir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax (Maximum Observed Concentration in Plasma) of MP-424
Time Frame: Data were collected at Day1 to Day85

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.

Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Data were collected at Day1 to Day85
Tmax (Time of Maximum Concentration in Plasma) of MP-424
Time Frame: Data were collected at Day1 to Day85

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.

Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Data were collected at Day1 to Day85
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
Time Frame: Data were collected at Day1 to Day85

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.

Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Data were collected at Day1 to Day85
Ctrough (Minimum Observed Concentration in Plasma) of MP-424
Time Frame: Data were collected at Day1 to Day85

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.

Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Data were collected at Day1 to Day85
T1/2(Time of Half-Life) of MP-424
Time Frame: Data were collected at Day1 to Day85

Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.

Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Data were collected at Day1 to Day85

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Time Frame: 37 weeks
HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2-7.8 log10 IU/mL.
37 weeks

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

April 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 24, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

March 6, 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G060-A5

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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