UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053897 |
|---|---|
| Receipt number | R000061524 |
| Scientific Title | Web-based Survey Study on Diagnosis and Testing of Acquired Hemophilia A (AHA) among Physicians in Japan |
| Date of disclosure of the study information | 2024/03/19 |
| Last modified on | 2026/01/26 15:32:29 |
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Basic information
Public title
Web-based Survey Study on Diagnosis and Testing of Acquired Hemophilia A (AHA) among Physicians in Japan
Acronym
Web-based Survey Study on Diagnosis and Testing of Acquired Hemophilia A (AHA) among Physicians in Japan
Scientific Title
Web-based Survey Study on Diagnosis and Testing of Acquired Hemophilia A (AHA) among Physicians in Japan
Scientific Title:Acronym
Web-based Survey Study on Diagnosis and Testing of Acquired Hemophilia A (AHA) among Physicians in Japan
Region
| Japan |
Condition
Condition
Acquired Hemophilia A
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
-To clarify the time to diagnosis of Acquired Hemophilia A (AHA) in Japan
-To clarify the time required for tests of AHA and tests leading to initiation of AHA treatment and investigate problems in diagnosis of AHA from hematologists' perspective in Japan
Basic objectives2
Others
Basic objectives -Others
Web-based Survey
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to diagnosis from onset of bleeding
-Time to visit/to admission to the department to which the target doctor belongs from onset of bleeding
-Time to diagnosis from patient's visit to the department to which the target doctor belongs
Key secondary outcomes
1.Test of AHA
-Test items, testing sites (in-hospital tests/outsourced tests)
-Time required for test of AHA
-Tests leading to initiation of AHA treatment
2.Issues on diagnosis and test of AHA as assessed by the following items
-Diagnosis test which is the cause of delay in obtaining the result for diagnosis
-Cause of the difficulty of diagnosis
-Cause of the wondering the interpretation of the result on diagnosis
-Referral process from other department
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
Physicians in hematology, emergency medicine, general internal medicine, general medicine, or pediatrics who have diagnosed or treated patients with AHA in the past three years before giving their consent
Key exclusion criteria
1. Physicians with less than two years of clinical experience at giving their consent (excluding residency)
2. Physicians working in facilities other than clinics, university hospitals, general hospitals, national and public hospitals at giving their consent
3. Physicians who are not treating either outpatients or inpatients at giving their consent
4. Physicians who require regal representatives
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Go |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo
TEL
090-1872-0300
madoka.go@takeda.com
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Go |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo
TEL
090-1872-0300
Homepage URL
madoka.go@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
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 Medical Association Building 4F, 2-5, Kanda-Surugadai, Chiyoda, Tokyo
Tel
03-3259-6177
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 | 03 | Month | 19 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_6310-25/_article/-char/en
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_6310-25/_article/-char/en
Number of participants that the trial has enrolled
112
Results
Among the 112 physicians analyzed, diagnostic delays were indicated, as a certain proportion of AHA cases required 8 days or more from bleeding onset to referral and from referral to diagnosis (31.3% and 23.2%, respectively). While aPTT and aPTT cross-mixing tests were performed rapidly in-house, FVIII activity and FVIII inhibitor tests were often outsourced and took longer to obtain results; difficulty interpreting test results (41.7%-76.2%) was also identified as a factor contributing to delays.
Results date posted
| 2026 | Year | 01 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Physicians who belong to the following clinical departments
･Hematology
･Emergency medicine
･General internal medicine
･General medicine
･Pediatrics
Participant flow
This study recruited participants from a physician panel, and informed consent and questionnaire responses were obtained via a dedicated web-based system.
Adverse events
N/A
Outcome measures
･Time to diagnosis from onset of bleeding
･Test of AHA
･Issues on diagnosis and test of AHA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 08 | Month | 31 | Day |
Other
Other related information
A prospective, cross-sectional, observational study. This study is a web survey for physicians in hematology, emergency medicine, general internal medicine, general medicine, or pediatrics who have diagnosed or treated patients with AHA in the past three years to collect information regarding the real-world condition of time required for diagnosis and initiation of AHA, and issues on diagnosis of AHA. It will be conducted for two weeks. The data obtained in this survey is anonymized and individuals cannot be identified.
Management information
Registered date
| 2024 | Year | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061524
