Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
NCT ID: NCT01753557
Last Updated: 2026-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
54 participants
INTERVENTIONAL
2012-12-31
2014-11-30
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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Treatment-Naive
MP-424
MP-424: 750mg every 8 hours (q8h) for 12 weeks
RBV
RBV: 600 - 1000 mg/day based on body weight for 24 weeks
PEG-IFN alfa-2a
PEG-IFN alfa-2a: 180mcg/week for 24 weeks
Treatment-Relapsed
MP-424
MP-424: 750mg every 8 hours (q8h) for 12 weeks
RBV
RBV: 600 - 1000 mg/day based on body weight for 24 weeks
PEG-IFN alfa-2a
PEG-IFN alfa-2a: 180mcg/week for 24 weeks
Interventions
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MP-424
MP-424: 750mg every 8 hours (q8h) for 12 weeks
RBV
RBV: 600 - 1000 mg/day based on body weight for 24 weeks
PEG-IFN alfa-2a
PEG-IFN alfa-2a: 180mcg/week for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* treatment-naïve or relapsers (patient who relapsed after previous treatment)
* Able and willing to follow contraception requirements
Exclusion Criteria
* 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
20 Years
65 Years
ALL
No
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kazuoki Kondo, M.D.
Role: STUDY_DIRECTOR
Tanabe Pharma Corporation
Locations
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Toranomon Hospital
Kawasaki, Takatsu-ku, Japan
Countries
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References
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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.
Other Identifiers
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G060-A12
Identifier Type: -
Identifier Source: org_study_id
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