search
Back to results

Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
MP-424
Ribavirin
Peginterferon Alfa-2b
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 Hepatitis C focused on measuring Chronic Hepatitis C, Protease Inhibitor, Telaprevir, Peginterferon Alfa-2b, Ribavirin

Eligibility Criteria

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

Inclusion Criteria:

  • Genotype 1, chronic hepatitis C
  • Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C)
  • 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 2

Arm Type

Experimental

Active Comparator

Arm Label

TRV/PEG/RBV

PEG/RBV

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 24, 2008
Last Updated
April 16, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
Collaborators
Vertex Pharmaceuticals Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT00780416
Brief Title
Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
Official Title
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Treatment-Naïve Subjects With Genotype 1 Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (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
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) 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, Telaprevir, Peginterferon Alfa-2b, Ribavirin

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
TRV/PEG/RBV
Arm Type
Experimental
Arm Title
PEG/RBV
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MP-424
Other Intervention Name(s)
Telaprevir
Intervention Description
750 mg every 8 hours for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
600 - 1000 mg/day based on body weight for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon Alfa-2b
Intervention Description
1.5 mcg/kg/week for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
600 - 1000 mg/day based on body weight for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon Alfa-2b
Intervention Description
1.5 mcg/kg/week for 48 weeks
Primary Outcome Measure Information:
Title
The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (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 1, chronic hepatitis C Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C) 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
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
21827730
Citation
Kumada H, Toyota J, Okanoue T, Chayama K, Tsubouchi H, Hayashi N. Telaprevir with peginterferon and ribavirin for treatment-naive patients chronically infected with HCV of genotype 1 in Japan. J Hepatol. 2012 Jan;56(1):78-84. doi: 10.1016/j.jhep.2011.07.016. Epub 2011 Aug 7.
Results Reference
result

Learn more about this trial

Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

We'll reach out to this number within 24 hrs