NCT06550882

A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea

Post-Marketing Surveillance (Use-result Surveillance) of OBIZUR Injection [Susoctocog Alpha (Porcine Antihemophilic Factor VIII, Recombinant)] for the Approved Indications in South Korea

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 9 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acquired hemophilia A (AHA) is a rare bleeding condition which prevents blood clotting. Acquired means that people are not born with this condition or have a family history of blood clotting conditions. People living with AHA can have sudden and severe bleeding. They also have longer bleeding compared to people without AHA. The main aim of the study is to learn how safe OBIZUR is in adults with AHA. Other aims are to see how effective OBIZUR is to control bleeding and how treatment is used in a routine clinical practice setting. The treatment of the participants will be determined by the treating physicians. During the study, data already existing in the participants' medical record and new data will be collected.

Detailed description

This is a prospective, and retrospective, multicenter, single-arm non-interventional post-marketing surveillance study.

Conditions

• Acquired Hemophilia A

Interventions

Type	Name	Description
DRUG	OBIZUR	OBIZUR injection.

Timeline

• Start date: 2025-07-22
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2024-08-13
• Last updated: 2025-08-12

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study