Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients
NCT ID: NCT01468584
Last Updated: 2026-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
10 participants
INTERVENTIONAL
2011-11-30
2013-09-30
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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MP-424
MP-424 (generic name:Telaprevir)
750mg q8h for 12 weeks
Ribavirin
400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b
1.5mcg/kg/week for 24 weeks
Interventions
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MP-424 (generic name:Telaprevir)
750mg q8h for 12 weeks
Ribavirin
400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b
1.5mcg/kg/week for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* Non-responders (patient who did not respond to 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
Responsible Party
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Principal Investigators
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Kazuoki Kondo, MD
Role: STUDY_DIRECTOR
Tanabe Pharma Corporation
Locations
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Toranomon Hospital
Minato-ku, Tokyo, Japan
Countries
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References
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Kumada H, Sato K, Takehara T, Nakamuta M, Ishigami M, Chayama K, Toyota J, Suzuki F, Nakayasu Y, Ochi M, Yamada I, Okanoue T. Efficacy of telaprevir-based therapy for difficult-to-treat patients with genotype 2 chronic hepatitis C in Japan. Hepatol Res. 2015 Jul;45(7):745-54. doi: 10.1111/hepr.12416. Epub 2014 Nov 18.
Other Identifiers
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G060-A11
Identifier Type: -
Identifier Source: org_study_id
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