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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MP-424 (Telaprevir)
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Chronic Hepatitis C, Protease Inhibitor

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toranomon Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MP-424

Arm Description

Outcomes

Primary Outcome Measures

Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration

Secondary Outcome Measures

Full Information

First Posted
February 12, 2008
Last Updated
April 16, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
Collaborators
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00621296
Brief Title
Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C
Official Title
Phase II Study of MP-424 in Patients With (Genotype 1b) Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
Collaborators
Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Chronic Hepatitis C, Protease Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MP-424
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MP-424 (Telaprevir)
Other Intervention Name(s)
Telaprevir
Intervention Description
Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)
Primary Outcome Measure Information:
Title
Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fumitaka Suzuki, MD
Organizational Affiliation
Department of Hepatology, Toranomon Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toranomon Hospital
City
Kawasaki City
State/Province
Takatsu-ku
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23383655
Citation
Toyota J, Ozeki I, Karino Y, Asahina Y, Izumi N, Takahashi S, Kawakami Y, Chayama K, Kamiya N, Aoki K, Yamada I, Suzuki Y, Suzuki F, Kumada H. Virological response and safety of 24-week telaprevir alone in Japanese patients infected with hepatitis C virus subtype 1b. J Viral Hepat. 2013 Mar;20(3):167-73. doi: 10.1111/j.1365-2893.2012.01640.x. Epub 2012 Jul 13.
Results Reference
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Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C

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