Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy
NCT ID: NCT00780910
Last Updated: 2026-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
109 participants
INTERVENTIONAL
2008-11-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MP-424
MP-424
750 mg every 8 hours for 12 weeks
Ribavirin
600 - 1000 mg/day based on body weight for 24 weeks
Peginterferon Alfa-2b
1.5 mcg/kg/week for 24 weeks
Interventions
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MP-424
750 mg every 8 hours for 12 weeks
Ribavirin
600 - 1000 mg/day based on body weight for 24 weeks
Peginterferon Alfa-2b
1.5 mcg/kg/week for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Relapsers (patient who relapsed after previous treatment)
* Able and willing to follow contraception requirements
Exclusion Criteria
* 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
20 Years
65 Years
ALL
No
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Fumitaka Suzuki, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Hepatology, Toranomon Hospital
Locations
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Toranomon Hospital
Kawasaki, Takatsu-ku, Japan
Countries
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References
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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.
Other Identifiers
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G060-A8
Identifier Type: -
Identifier Source: org_study_id
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