UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057958 |
|---|---|
| Receipt number | R000065972 |
| Scientific Title | Long-term risk factors for hemophilic arthropathy in patients with severe hemophilia A: A 36-year retrospective cohort study |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2026/01/26 20:33:41 |
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Basic information
Public title
A Study on the Onset and Course of Hemophilic Arthropathy in Hemophilia Patients
Acronym
Research on the onset and course of hemophilic arthropathy
Scientific Title
Long-term risk factors for hemophilic arthropathy in patients with severe hemophilia A: A 36-year retrospective cohort study
Scientific Title:Acronym
Analysis of the Risk of Hemophilic Arthropathy in Patients with Severe Hemophilia A
Region
| Japan |
Condition
Condition
severe hemophilia A
Classification by specialty
| Hematology and clinical oncology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to identify the risk of developing stage IV or higher joint arthropathy, as per the Arnold-Hilgartner classification, hemophilia A cases, by examining the timing and age at which regular prophylaxis was initiated for elbow, knee, and ankle joints.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of the initiation of prophylaxis on the development of hemophilic arthropathy in the elbows, knees, and ankles.
Key secondary outcomes
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
Key inclusion criteria
It targeted cases of male severe Hemophilia A who visited our facility's outpatient clinic from 1984 to 2020 and did not have inhibitors, which FVIII.
Key exclusion criteria
Not particularly
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Suzuki |
Organization
University of Occupational and Environmental Health
Division name
Department of Orthopedics
Zip code
8078555
Address
1-1 Iseigaoka, Yahatanishi, Kitakyushu, Fukuoka, Japan
TEL
81-93-603-1611
belltree@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Suzuki |
Organization
Center for Clinical Research Promotion
Division name
Division of Clinical Research
Zip code
8078555
Address
1-1 Iseigaoka, Yahatanishi, Kitakyushu, Fukuoka, Japan
TEL
81-93-603-1611
Homepage URL
rinshokenkyu@mbox.clnc.uoeh-u.ac.jp
Sponsor or person
Institute
Univesity of Occupational and Environmental Health
Institute
Department
Personal name
Hitoshi Suzuki
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Medicine, the University of Occupational and Environmental Health
Address
1-1 Iseigaoka, Yahatanishi, Kitakyushu, Fukuoka, Japan
Tel
81-93-603-1611
rinshokenkyu@mbox.clnc.uoeh-u.ac.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
産業医科大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 01 | 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
109
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Simple X-ray photographs of elbow, knee, and ankle joints were taken from the front and side, and arthropathy was evaluated according to the classification. The onset of HA was defined as Stage IV or higher, indicating narrowing of the joint space. The age at which regular prophylaxis recorded, and cases receiving standard half-life products at a rate of >2.5 infusions/week for more than 45 weeks/year were defined as having prophylaxis (extended half-life FVIII and emicizumab had not been introduced at that time). Patients who were suspended the above-mentioned excluded from the analysis from the time when they were no longer included in the study.
Management information
Registered date
| 2025 | Year | 05 | Month | 24 | 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=R000065972
