UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047206 |
|---|---|
| Receipt number | R000053847 |
| Scientific Title | Obtain Real World Insights of Acquired Hemophilia A Patients in Japan2 |
| Date of disclosure of the study information | 2022/03/17 |
| Last modified on | 2022/03/17 22:00:29 |
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Basic information
Public title
Obtain Real World Insights of Acquired Hemophilia A Patients in Japan2
Acronym
ORIHIME2 study
Scientific Title
Obtain Real World Insights of Acquired Hemophilia A Patients in Japan2
Scientific Title:Acronym
ORIHIME2 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
To evaluate the relationship between patient background, drug use, and outcome among patients with acquired hemophilia A who underwent rehabilitation or low ADL scores between April 1, 2008 and October 31, 2021.
Basic objectives2
Others
Basic objectives -Others
-
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following outcome measures will be set. In this study, the outcome measures will be analyzed for overall and each target segment (rehabilitation initiation time, period of immunosuppressant use, hospitalization period, ADL on discharge, hemorrhage, type of infection and Death).
1)Treatment implementation status
A)Rehabilitation implementation status
Type of rehabilitation, frequency, period up to initiation, duration of continuation
2)Outcome
A)ADL on discharge
Key secondary outcomes
The following outcome measures will be set. In this study, the outcome measures will be analyzed for overall and each target segment (rehabilitation initiation time, period of immunosuppressant use, hospitalization period, ADL on discharge, hemorrhage, type of infection and Death).
1)Epidemiology
A)Age/sex
B)Comorbidity disease
2)Treatment implementation status
A)Use status of hemostatic agents
Type of hemostatic agent, initial date of use, period of use
B)Use status of immunosuppressants
Type of immunosuppressant, amount used, period of use
C)Hospitalization period
3) Outcome
A)Hemorrhage
B)Hospital transfer destination
C)Infection
D)Thromboembolism
E)Death
F)Nursing care level
G)Dysphagia
H)Bedsores
I)Criteria for determining the level of independence in daily living for elderly persons with dementia
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 must satisfy all of the following criteria to be considered eligible for this study.
1)Of the patients assigned the receipt disease name,[acquired coagulation factor deficiency (disease code: D684)], those who are assigned the receipt disease name, [acquired hemophilia A] (confirmed)
2)Patients who were admitted on the date the receipt disease name, [acquired hemophilia A] (confirmed) was assigned
3)Patients with data on administration of an immunosuppressant subsequent to the date of initial admission among admissions with the assigned receipt disease name, [AHA] (confirmed)
Key exclusion criteria
Patients for whom any of the following criteria apply will be excluded from this study. The entire observation period will apply for all criteria.
1)Patients assigned the receipt disease name, [antiphospholipid syndrome] (confirmed)
2)Patients assigned the receipt disease name, [lupus anticoagulant] (confirmed)
3)Patients assigned the receipt disease name, [acquired coagulation factor XIII deficiency] (confirmed)
4)Patients assigned the receipt disease name, [autoimmune acquired Von Willebrand's disease] (confirmed)
5)Patients assigned the receipt disease name, [acquired factor V deficiency] (confirmed)
6) Patients assigned the receipt idisease name [primary antiphospholipid antibody syndrome] (confirmed)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Nakagawa |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Medical Science 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 | Chugai Pharmaceutical |
| Middle name | |
| Last name | Co., Ltd. |
Organization
Medical affairs department
Division name
Medical Science department
Zip code
103-8324
Address
2-1-1 Muromachi, Nihonbashi, Chuo-ku, Tokyo
TEL
03-3273-0866
Homepage URL
cma-clinicaltrial@chugai-pharm.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
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
| 2022 | Year | 03 | Month | 17 | 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
| 2022 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2022 | Year | 03 | Month | 17 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053847
