HEMLIBRA Subcutaneous injection General Drug Use Surveillance(in Hemophilia A with Inhibitors).

HEMLIBRA Subcutaneous injection General Drug Use Surveillance(in Hemophilia A with Inhibitors). - HEMLIBRA General Drug Use Surveillance(in Hemophilia A).

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000032515

Enrollment

100

Registered

2018-05-21

Start date

2018-05-22

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: All patients(Inhibitor hemophilia A) who are scheduled to receive HEMLIBRA at contracted institutions during.

Exclusion criteria

Exclusion criteria: No criteria

Design outcomes

Primary

Measure	Time frame
1. The incidence of ADRs. 2. The incidence of TE and/or TMA (including the time to onset, outcome, treatment state etc.) 3. Treatment state on the occurrence of TE and/or TMA.(including bypassing agents, treatment period, dosage volume etc. of Hemlibra and bypassing agents.) 4. Treatment state on the occurrence of bleeding of Hemlibra and Bypassing agents (including agents name, treatment period, dosage volume etc.)	—

Measure

Time frame

1. The incidence of ADRs. 2. The incidence of TE and/or TMA (including the time to onset, outcome, treatment state etc.) 3. Treatment state on the occurrence of TE and/or TMA.(including bypassing agents, treatment period, dosage volume etc. of Hemlibra and bypassing agents.) 4. Treatment state on the occurrence of bleeding of Hemlibra and Bypassing agents (including agents name, treatment period, dosage volume etc.)

—

Secondary

Measure	Time frame
- The time to onset of ADRs. - The treatment status and outcome of ADRs. - Occurrence state of bleeding. - Annualized Bleeding Rate (ABR).	—

Countries

Japan

Contacts

Public ContactAyako Murayama

Chugai Pharmaceutical Co. Ltd. Safety science 2 Dept.

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

Outcome results