Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
NCT ID: NCT05667064
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-05-10
2026-12-31
Brief Summary
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Detailed Description
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The investigation will be conducted as one of the additional pharmacovigilance activities in the Japan Risk Management Plan of IMJUDO and IMFINZI in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for reexamination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Toshimitsu Tokimoto
Role: STUDY_DIRECTOR
AstraZeneca KK
Locations
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Research Site
Aichi, , Japan
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Aichi, , Japan
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Aichi, , Japan
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Akita, , Japan
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Aomori, , Japan
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Aomori, , Japan
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Chiba, , Japan
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Chiba, , Japan
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Ehime, , Japan
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Ehime, , Japan
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Fukui, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukushima, , Japan
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Gifu, , Japan
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Gifu, , Japan
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Gunma, , Japan
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Gunma, , Japan
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Hiroshima, , Japan
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Hiroshima, , Japan
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Hiroshima, , Japan
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Hokkaido, , Japan
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Hokkaido, , Japan
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Hokkaido, , Japan
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Hyōgo, , Japan
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Hyōgo, , Japan
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Hyōgo, , Japan
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Ibaraki, , Japan
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Ishikawa, , Japan
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Ishikawa, , Japan
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Kagawa, , Japan
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Kagawa, , Japan
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Kagoshima, , Japan
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Kagoshima, , Japan
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Kanagawa, , Japan
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Kochi, , Japan
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Kochi, , Japan
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Kumamoto, , Japan
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Kyoto, , Japan
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Kyoto, , Japan
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Mie, , Japan
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Mie, , Japan
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Miyagi, , Japan
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Miyazaki, , Japan
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Miyazaki, , Japan
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Nagano, , Japan
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Nagasaki, , Japan
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Nara, , Japan
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Nara, , Japan
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Niigata, , Japan
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Numakunai, , Japan
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Okayama, , Japan
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Okayama, , Japan
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Okinawa, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Ōita, , Japan
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Ōita, , Japan
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Saga, , Japan
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Saitama, , Japan
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Saitama, , Japan
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Shiga, , Japan
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Shimane, , Japan
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Shimane, , Japan
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Shimane, , Japan
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Shizuoka, , Japan
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Shizuoka, , Japan
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Tochigi, , Japan
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Tochigi, , Japan
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Tokushima, , Japan
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Tokushima, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tottori, , Japan
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Toyama, , Japan
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Wakayama, , Japan
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Wakayama, , Japan
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Yamagata, , Japan
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Yamaguchi, , Japan
Research Site
Yamaguchi, , Japan
Research Site
Yamanashi, , Japan
Countries
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Central Contacts
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Other Identifiers
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D419CC00026
Identifier Type: -
Identifier Source: org_study_id
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