Study Results
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View full resultsBasic Information
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COMPLETED
6 participants
OBSERVATIONAL
2016-11-16
2022-05-11
Brief Summary
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1. Unexpected adverse drug reactions
2. Occurrence of adverse drug reactions in the actual clinical use
3. Factors that may affect safety and effectiveness
4. Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX deficiency
5. Safety and effectiveness for hemophilia B patients who received routine prophylactic therapy, on-demand therapy and perioperative therapy
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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All Study Participants
RIXUBIS
Interventions
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RIXUBIS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Takeda
INDUSTRY
Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Shire
Locations
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Seki-shi, Japan
Seki-shi, Gifu, Japan
Maebashi-shi, Japan
Maebashi, Gunma, Japan
Nobeoka-shi, Japan
Nobeoka-shi, Miyazaki, Japan
Niigata-shi, Japan
Niigata, Niigata, Japan
Osaka-shi, Japan
Osaka, Osaka, Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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251601
Identifier Type: -
Identifier Source: org_study_id
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