HEMLIBRA Subcutaneous injection Special Drug Use Surveillance (with Hemophilia A without Inhibitors).

HEMLIBRA Subcutaneous injection Special Drug Use Surveillance (with Hemophilia A without Inhibitors). - HEMLIBRA Special Drug Use Surveillance (with Hemophilia A without Inhibitors).

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037503

Enrollment

Registered

2019-07-27

Start date

2019-06-24

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

Hemophilia A

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients in contracted site meet all of the following criteria 1) to 3). 1) Patients with Hemophilia A without Inhibitors. 2) Patients who receive first HEMLIBRA administration from June, 2019 to June, 2020 (exclude previous administration history in other sites). 3) Patients who receive FVIII in follow up period (except for patients who receive only FVIII as regular continuous replacement therapy until a day before second dose of HEMLIBRA).

Exclusion criteria

Exclusion criteria: No criteria

Design outcomes

Primary

Measure	Time frame
1. The incidence of thrombotic ADR in patients with FVIII agents. 2. The incidence (time to onset, outcome, treatment state) of thrombotic ADR (thromboembolisms and thrombotic microangiopathy). 3. Dose (type, duration, dosage, reason of administration) of FVIII and HEMLIBRA in patient with thrombotic ADR (thromboembolisms and thrombotic microangiopathy) . 4. Dose (class, duration, dosage, reason of administration) of FVIII in 1 year from first HEMLIBRA administration.	—

Measure

Time frame

1. The incidence of thrombotic ADR in patients with FVIII agents. 2. The incidence (time to onset, outcome, treatment state) of thrombotic ADR (thromboembolisms and thrombotic microangiopathy). 3. Dose (type, duration, dosage, reason of administration) of FVIII and HEMLIBRA in patient with thrombotic ADR (thromboembolisms and thrombotic microangiopathy) . 4. Dose (class, duration, dosage, reason of administration) of FVIII in 1 year from first HEMLIBRA administration.

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Countries

Japan

Contacts

Public ContactRyousuke Harada

Chugai Pharmaceutical Co. Ltd. Safety science Dept.

haradarus@chugai-pharm.co.jp03-3281-6611

Outcome results