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HIghlight the unKnOwn Burden of HemOphilia A using the JapaneSe Healthcare claIms and medical record database

Database Study of Treatment Burden and State of Medical Care with Existing Treatments in Patients with Congenital Hemophilia A - HIKOBOSHI study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000043484
Enrollment
400
Registered
2021-03-01
Start date
2021-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital hemophilia A

Interventions

None listed

Sponsors

Chugai Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactChugai Pharmaceutical Co., Ltd.

Medical affairs department Medical Science department

cma-clinicaltrial@chugai-pharm.co.jp03-3273-0866

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026