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Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)

Primary Purpose

Chronic Hepatitis C(CHC)

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
MP-424
RBV(24 weeks)
IFN beta(24 weeks)
RBV(48 weeks)
IFN beta(48 weeks)
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 Feron

Eligibility Criteria

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

Inclusion Criteria:

  • Genotype 1 or 2, chronic hepatitis C, with depression(including the past)
  • Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based 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 serious 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 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MP-424+RBV+IFN beta, Genotype1

RBV+IFN beta, Genotype1

MP-424+RBV+IFN beta, Genotype2

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
Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.
To examine the emergence of resistance-associated variants after MP-424 administration.

Full Information

First Posted
December 13, 2012
Last Updated
January 5, 2018
Sponsor
Mitsubishi Tanabe Pharma Corporation
Collaborators
Toray Industries, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01753570
Brief Title
Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)
Official Title
A Phase 3 Study of MP-424 in Combination With IFN Beta and RBV, in Subjects With Genotype 1/2 Hepatitis C, Who Are Treatment-Naïve or Have Received Interferon Based Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
Collaborators
Toray Industries, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C(CHC)
Keywords
Feron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MP-424+RBV+IFN beta, Genotype1
Arm Type
Experimental
Arm Title
RBV+IFN beta, Genotype1
Arm Type
Experimental
Arm Title
MP-424+RBV+IFN beta, Genotype2
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(24 weeks)
Intervention Description
RBV: 600 - 1000mg/day based on body weight for 24 weeks
Intervention Type
Drug
Intervention Name(s)
IFN beta(24 weeks)
Intervention Description
IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks
Intervention Type
Drug
Intervention Name(s)
RBV(48 weeks)
Intervention Description
RBV: 600 - 1000mg/day based on body weight for 48 weeks
Intervention Type
Drug
Intervention Name(s)
IFN beta(48 weeks)
Intervention Description
IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 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
72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)
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
48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta)
Title
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
Time Frame
60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta)
Title
Transition of Serum HCV RNA Levels
Time Frame
Baseline，Day2，Day3，1Week，2Weeks，3Weeks，4Weeks，12Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks
Title
Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.
Description
To examine the emergence of resistance-associated variants after MP-424 administration.
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
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Genotype 1 or 2, chronic hepatitis C, with depression(including the past) Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based 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 serious 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
28497489
Citation
Kumada H, Mochida S, Nakamuta M, Suzuki F, Yagi T, Takasaki R, Okai M, Kamiya N, Okada Y, Hirota S, Orihashi M, Ochi M, Chayama K. Efficacy and safety of telaprevir with natural human interferon-beta and ribavirin in Japanese chronic hepatitis C patients with depression. Hepatol Res. 2018 Feb;48(2):184-192. doi: 10.1111/hepr.12914. Epub 2017 Jul 19.
Results Reference
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Learn more about this trial

Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)

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