Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin (RBV) in Subjects With (Genotype 1) Hepatitis C Who Did Not Respond to Previous Treatment
1 other identifier
interventional
32
1 country
1
Brief Summary
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2008
CompletedFirst Posted
Study publicly available on registry
October 28, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
August 20, 2012
CompletedJanuary 6, 2026
December 1, 2025
1.6 years
October 24, 2008
June 5, 2012
December 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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)
After 24 weeks of follow-up
Study Arms (1)
MP-424
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Genotype 1, chronic hepatitis C
- Non-responders (patient who did not respond to previous treatment)
- Able and willing to follow contraception requirements
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanabe Pharma Corporationlead
- Vertex Pharmaceuticals Incorporatedcollaborator
Study Sites (1)
Toranomon Hospital
Kawasaki, Takatsu-ku, Japan
Related Publications (1)
Hayashi N, Okanoue T, Tsubouchi H, Toyota J, Chayama K, Kumada H. Efficacy and safety of telaprevir, a new protease inhibitor, for difficult-to-treat patients with genotype 1 chronic hepatitis C. J Viral Hepat. 2012 Feb;19(2):e134-42. doi: 10.1111/j.1365-2893.2011.01528.x. Epub 2011 Nov 8.
PMID: 22239511RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials, Information Desk
- Organization
- Tanabe Pharma Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Fumitaka Suzuki, MD
Department of Hepatology, Toranomon Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2008
First Posted
October 28, 2008
Study Start
December 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
January 6, 2026
Results First Posted
August 20, 2012
Record last verified: 2025-12