Efanesoctocog Alfa Multicenter Prospective Observational Study in patients with factor VIII deficiency in Japan Protocol No.OBS17793

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031240049

Enrollment

150

Registered

2024-04-25

Start date

2024-06-04

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Patients with blood coagulation factor VIII deficiency efanesoctocog alfa : recombinant Factor VIII

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who understand the purposes and risks of this study and voluntarily give written informed consent to participate in this study *If the patient is under 16 years of age, or if the patient has completed junior high school or is 16<= and <18 years of age and is judged to have insufficient judgment capability, the consent of the legal representative shall be obtained. 2.Patients with coagulation factor VIII deficiency who are scheduled to receive efanesoctocog alfa or have started treatment within the past 8 months (240 days) *Regardless of age, sex, hemophilia severity (FVIII activity), prior FVIII treatment, and presence of previous inhibitors.

Exclusion criteria

Exclusion criteria: Patients unable or unwilling to provide informed consent

Design outcomes

Primary

Measure	Time frame
To collect and assess the safety information of efanesoctocog alfa in clinical practice	—

Secondary

Measure	Time frame
-Assessment of prophylaxis treatment -Assessment of bleeding during prophylaxis treatment -Assessment of treatment for acute bleeding in patients during prophylaxis therapy and on demand therapy -Assessment during perioperative period -Adverse events (AEs) -Impact on Quality of Life (QOL) of patients	—

Contacts

Public ContactIkue Konishi

CMIC Co.,Ltd.

X-ceed_jimu@cmic.co.jp+81-3-6779-8000

Outcome results