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Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
MP-424 (generic name:Telaprevir)
Ribavirin
Peginterferon alfa-2b
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Genotype 2

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Genotype 2, 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

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 (SVR, Sustained Viral Response)

Secondary Outcome Measures

Full Information

First Posted
November 2, 2011
Last Updated
October 29, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01466192
Brief Title
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients
Official Title
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 2 Hepatitis C, Who Relapsed After Previous Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Genotype 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MP-424
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MP-424 (generic name:Telaprevir)
Intervention Description
750mg q8h for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
400 - 1000 mg/day based on body weight for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2b
Intervention Description
1.5mcg/kg/week for 24 weeks
Primary Outcome Measure Information:
Title
Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
Time Frame
After 24 weeks of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Genotype 2, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Toranomon Hospital
City
Minato-ku
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25196718
Citation
Kumada H, Sato K, Takehara T, Nakamuta M, Ishigami M, Chayama K, Toyota J, Suzuki F, Nakayasu Y, Ochi M, Yamada I, Okanoue T. Efficacy of telaprevir-based therapy for difficult-to-treat patients with genotype 2 chronic hepatitis C in Japan. Hepatol Res. 2015 Jul;45(7):745-54. doi: 10.1111/hepr.12416. Epub 2014 Nov 18.
Results Reference
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Learn more about this trial

Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients

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