UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043484 |
|---|---|
| Receipt number | R000049647 |
| Scientific Title | Database Study of Treatment Burden and State of Medical Care with Existing Treatments in Patients with Congenital Hemophilia A |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2022/11/07 19:57:40 |
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Basic information
Public title
HIghlight the unKnOwn Burden of HemOphilia A using the JapaneSe Healthcare claIms and medical record database
Acronym
HIKOBOSHI study
Scientific Title
Database Study of Treatment Burden and State of Medical Care with Existing Treatments in Patients with Congenital Hemophilia A
Scientific Title:Acronym
HIKOBOSHI study
Region
| Japan |
Condition
Condition
Congenital hemophilia A
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe treatment patterns of congenital hemophilia A in Japan and study the disease burden through quantifying patients background, Medical practices , Laboratory test, Healthcare resource utilization, concurrent disease, Clinical Outcome: intracranial hemorrhage and ischemic heart disease in the Japanese healthcare claims and medical record database (medical databases).
Basic objectives2
Others
Basic objectives -Others
-
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The outcome measures are as follows. Note that the number of hospitals visited will only be defined for JMDC database, and whether or not the patient has inhibitors and the minimum FVIII activity will only be defined for RWD database, which is able to use the test data.
A:Patient Background (A-1 Age, A-2 Sex, A-3 Observation period, A-4 Insurance subscriber attribute)
B: Clinical outcomes (B-1 Intracranial Hemorrhage, B-2 Ischemic Heart disease)
C: Medical practices (C-1 Hospitalizations, C-2 Out-of-hours visits, C-3 Outpatient visits, C-4 Number of hospitals visited, C-5 Prescription amount of FVIII concentrates C-6 Prescription amount of Bypassing agents, C-7 Prescription amount of Emicizumab, C-8 Prescriptions for analgesic drugs, C-9 Prescriptions for antiplatelet drug/anticoagulants for thrombotic disorders, C-10 Joint surgery/treatment, C-11 Insertion od Romoval of central venous access device, C-12 Rehabilitation)
D: Laboratory tests (D-1 History of inhibitor possession and inhibitor titer, D-2 Minimum FVIII activity)
E: Healthcare resource utilization (E-1 Surgical/treatment expenses, E-2 Drug product expenses, E-3 Test expenses )
F. Concurrent disease (diabetes, hypertension, atrial fibrillation, cerebral thrombosis/embolism, hyperlipidemia, arteriosclerosis, chronic renal failure [including blood/peritoneal dialysis/kidney transplant], osteoporosis, malignant tumor, HCV, HIV, thrombotic microangiopathy [TMA], venous thrombosis, dementia, nervous system disorders, and mental and behavioral disorders)
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 and Female
Key inclusion criteria
Patients who were diagnosed with congenital hemophilia A (Patients with an ICD-10 subdivision code of D66) during the observation period and have been prescribed a FVIII concentrate, emicizumab, or bypassing agents
Key exclusion criteria
Patients with only one month of observation in the JMDC database and patients with only one day of observation in the RWD database.
Patients who were hospitalized on the observation start month and died within same month of hospitalization in the JMDC database and patients who were hospitalized on the observation start date and died within one week of hospitalization in the RWD database.
Target sample size
400
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 | 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
Address
1-15-14 Dougenzaka,Shibuya-ku,Tokyo
Tel
03-6416-1868
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/36320425/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36320425/
Number of participants that the trial has enrolled
459
Results
Res Pract Thromb Haemost.2022 Oct 28;6(7):e12825
Results date posted
| 2022 | Year | 11 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Res Pract Thromb Haemost.2022 Oct 28;6(7):e12825
Participant flow
Res Pract Thromb Haemost.2022 Oct 28;6(7):e12825
Adverse events
Res Pract Thromb Haemost.2022 Oct 28;6(7):e12825
Outcome measures
Res Pract Thromb Haemost.2022 Oct 28;6(7):e12825
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 | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 30 | Day |
Other
Other related information
-
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049647
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