UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043479 |
|---|---|
| Receipt number | R000049645 |
| Scientific Title | Obtain Real World Insights of Acquired Hemophilia A Patients in Japan |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2022/11/21 15:53:00 |
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Basic information
Public title
Obtain Real World Insights of Acquired Hemophilia A Patients in Japan
Acronym
ORIHIME study
Scientific Title
Obtain Real World Insights of Acquired Hemophilia A Patients in Japan
Scientific Title:Acronym
ORIHIME study
Region
| Japan |
Condition
Condition
Acquired hemophilia A
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the real world epidemiological and therapeutic state of acquired hemophilia A (AHA) in actual clinical practice in Japan using a medical information database of medical institutions subject to the Diagnosis Procedure Combination (DPC)
Basic objectives2
Others
Basic objectives -Others
epidemiological research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Initial use status of hemostatic agents: amount used, number of times used, number of days used according to type
-Use status of immunosuppressants: amount used, number of times used, number of days used according to type
-Onset of thromboembolism
-Deaths
Key secondary outcomes
Epidemiology
-Breakdown of concurrent diseases: malignant tumors, autoimmune diseases. skin diseases, others and pregnancy, delivery at around the time of AHA diagnosis
-Age distribution, sex distribution at the time of diagnosis
-Breakdown of hospital departments at the time of diagnosis
Hospitalizations
-Number of hospitalizations
-Hospitalization period
Treatment implementation status
-Transfusion implementation status
-Implementation status of plasmapheresis
-Implementation status of rehabilitation
Outcome
-Hemorrhage
-Onset of infections
-Activities of daily living (ADL) at admission and at discharge
-Breakdown of concurrent diseases with deaths
-Death risk factor analysis
-Infection risk factor analysis
-Thromboembolism risk factor analysis
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
Patients with acquired hemophilia A
Key exclusion criteria
Patients with antiphospholipid syndrome, lupus anticoagulant, acquired coagulation factor XIII deficiency, autoimmune acquired Von Willebrand's disease, acquired factor V deficiency
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Ouchi |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Medical affairs department
Zip code
103-8324
Address
2-1-1 Muromachi, Nihonbashi, Chuo-ku, Tokyo
TEL
03-3273-0866
cma-clinicaltrial@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Imokawa |
Organization
A2 Healthcare Corporation
Division name
GPSP Division and Data Science Division
Zip code
112-0002
Address
Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3830-1088
Homepage URL
imokawa-y@a2healthcare.com
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
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel
0364161868
npo-mins@j-irb.com
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
| 2021 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36331704/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36331704/
Number of participants that the trial has enrolled
338
Results
https://pubmed.ncbi.nlm.nih.gov/36331704/
Results date posted
| 2022 | Year | 11 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://pubmed.ncbi.nlm.nih.gov/36331704/
Participant flow
https://pubmed.ncbi.nlm.nih.gov/36331704/
Adverse events
https://pubmed.ncbi.nlm.nih.gov/36331704/
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/36331704/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective observational study using secondary data from medical claims database
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049645
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
