UMIN-CTR Clinical Trial

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
Email	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
Email	imokawa-y@a2healthcare.com

Sponsor
Institute	Chugai Pharmaceutical Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049645