UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055156 |
|---|---|
| Receipt number | R000063017 |
| Scientific Title | Obtain Real World Insights of Acquired Hemophilia A Patients in Japan III |
| Date of disclosure of the study information | 2024/08/08 |
| Last modified on | 2025/08/12 08:58:43 |
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Basic information
Public title
Obtain Real World Insights of Acquired Hemophilia A Patients in Japan III
Acronym
ORIHIME III study
Scientific Title
Obtain Real World Insights of Acquired Hemophilia A Patients in Japan III
Scientific Title:Acronym
ORIHIME III study
Region
| Japan |
Condition
Condition
Acquired hemophilia A
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to describe the treatment practice and clinical outcomes in patients with acquired hemophilia A (AHA) who received emicizumab during the period from April 1, 2012 to June 30, 2024. The secondary objective of this study is to evaluate patient background and clinical outcomes in patients with or without emicizumab, respectively.
Basic objectives2
Others
Basic objectives -Others
Descriptive and Outcome Research of Retrospective Observational Study by Secondary Use of Public Health Care Database (NDB, DPC-DB, LTC-DB)
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Current treatment status in patients with emicizumab
Actual use status of emicizumab, immunosuppressants, hemostatic agents and blood transfusions, rehabilitation, and duration of hospitalization
Clinical outcomes in patients with emicizumab
ADL (activities of daily living) at discharge, haemorrhage
Key secondary outcomes
Current treatment status in patients without emicizumab
Actual use status of immunosuppressants, hemostatic agents and blood transfusions, rehabilitation, and duration of hospitalization
Clinical outcomes in patients without emicizumab
ADL (activities of daily living) at discharge, haemorrhage
Other clinical outcomes in patients with or without emicizumab
Presence and time of onset of infection and thromboembolism, level of nursing care need after discharge and ADL (activities of daily living of nursing certified information in LTC-DB) and its changes from before hospitalization, recurrence of AHA, place of discharge, presence of dysphagia at admission, discharge and after discharge, presence of pressure sore at admission, discharge and after discharge, bleeding free survival time
Medical expenses (drug expenses for treatment of acquired hemophilia A [bleed control/hemostatic drugs])
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Emi cohort inclusion criteria
Patients who meet all of the following criteria will be included in the study.
1)Patients who have been given a claim injury/disease name of acquired hemophilia A
2)Patients for whom the health insurance claim for hospitalization has a health insurance claim name of acquired hemophilia A
3)Patients with prescription data of emicizumab from hospital admission given a health insurance claim injury name Acquired haemophilia A to the day before the next Index Date, the last receipt date, or the last day of the period covered by this data, whichever comes earlier
Non-Emi Cohort Enrollment Criteria
Patients who meet all of the following criteria will be included in the study.
1)Patients who have been given a claim injury/disease name of acquired hemophilia A
2)Patients for whom the health insurance claim for hospitalization has a health insurance claim name of acquired hemophilia A
3)Patients with prescription data of immunosuppressants during hospitalization given a health insurance claim injury name acquired hemophilia A
4)Hospitalization for which a health insurance claim injury name acquired hemophilia A was given, for which data on FVIII activity test or FVIII inhibitor titer test were obtained at least twice before the last day of the target period
Key exclusion criteria
Emi Cohort Exclusion Criteria
Patients with any of the following injury/disease name data will be excluded from the study. All data periods are included.
1)Patients who have been given a claim injury/disease name of antiphospholipid antibody syndrome
2)Patients who have been given a claim injury/disease name of lupus anticoagulant
3)Patients with a claim injury/disease name of acquired factor XIII deficiency
4)Patients with a health insurance claim injury/disease name of autoimmune acquired Von Willebrand's disease
5)Patients with a claim injury/disease name of acquired factor V deficiency
6)Patients with a claim injury/disease name of primary antiphospholipid antibody syndrome
Non-Emi Cohort Exclusion Criteria
In addition to the same exclusion criteria as those for the Emi cohort, cases where prescription data of emicizumab exist during the period from the Index Date to the day before the next Index Date, the date of occurrence of the last receipt, or the last date of the period covered by this data, whichever comes earlier, will be excluded.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Ioka |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Medical affairs division
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-chome, Nihonbashi Mitsui Tower (Reception 12F) Chuo-ku, Tokyo
TEL
03-3273-0866
kawano.mika64@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ayumu |
| Middle name | |
| Last name | Matsuoka |
Organization
NTT DATA Japan Corporation
Division name
Healthcare Division
Zip code
135-8671
Address
Toyosu Center Bldg. Annex, 3-3-9, Toyosu, Koto-ku, Tokyo
TEL
050-5546-7992
Homepage URL
data_science@kits.nttdata.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Physicians Association Institutional Review Board
Address
Tokyo Physician Building 4F, 2-5 Kanda-Surugadai, Chiyoda-ku, Tokyo
Tel
03-3259-6111
irb@nichirinnai.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063017
