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Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

Primary Purpose

Chronic Hepatitis C (CHC)

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
MP-424
RBV
PEG-IFN alfa-2a
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 (CHC) focused on measuring Pegasys

Eligibility Criteria

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

Inclusion Criteria:

  • Genotype 1 CHC
  • treatment-naïve or 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 (Human Immunodeficiency Virus) 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 2

Arm Type

Experimental

Experimental

Arm Label

Treatment-Naive

Treatment-Relapsed

Arm Description

Outcomes

Primary Outcome Measures

Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

Secondary Outcome Measures

Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)
Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
Transition of Serum HCV RNA Levels
Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)

Full Information

First Posted
December 13, 2012
Last Updated
August 9, 2016
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01753557
Brief Title
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
Official Title
A Phase 3 Study of MP-424 in Combination With PEG-IFN Alfa-2a and RBV, in Subjects With Genotype 1 Hepatitis C, Who Are Treatment-Naïve or Relapsed After Previous Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (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 PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or 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 (CHC)
Keywords
Pegasys

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment-Naive
Arm Type
Experimental
Arm Title
Treatment-Relapsed
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MP-424
Intervention Description
MP-424: 750mg every 8 hours (q8h) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
RBV: 600 - 1000 mg/day based on body weight for 24 weeks
Intervention Type
Drug
Intervention Name(s)
PEG-IFN alfa-2a
Intervention Description
PEG-IFN alfa-2a: 180mcg/week for 24 weeks
Primary Outcome Measure Information:
Title
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)
Time Frame
4 weeks
Title
Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)
Time Frame
24 weeks
Title
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
Time Frame
36 weeks
Title
Transition of Serum HCV RNA Levels
Time Frame
baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks
Title
Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)
Time Frame
From baseline to 24 weeks after completion of drug administration

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 1 CHC treatment-naïve or 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 (Human Immunodeficiency Virus) 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, M.D.
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Toranomon Hospital
City
Kawasaki City
State/Province
Takatsu-ku
ZIP/Postal Code
213-8587
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27062488
Citation
Kumada H, Suzuki F, Kamiya N, Orihashi M, Nakayasu Y, Yamada I. Efficacy and safety of telaprevir with pegylated interferon alpha-2a and ribavirin in Japanese patients. Hepatol Res. 2017 May;47(6):514-521. doi: 10.1111/hepr.12722. Epub 2016 Jun 4.
Results Reference
result

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Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

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