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
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants with AHA.

• Participants who are determined to have the clinical need to receive Obizur treatment.

• Participants aged 18 years or older at time of initiation of Obizur treatment.

• Participants agreed to participate in the study and voluntarily signed the informed consent.

Locations
Other Locations
Republic of Korea
Kyung Hee University Hospital at Gangdong
RECRUITING
Seoul
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2025-07-22
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 9
Treatments
All Participants
Participants with AHA who are receiving OBIZUR injection or initiate OBIZUR Injection treatment for the first time will be enrolled. Both retrospective and prospective participants data will be collected. Retrospective data will be collected from the date of first treatment with OBIZUR injection after the marketing authorization in Korea but before date of signed informed consent and prospective data will be collected from the date of signed informed consent. The treatment and follow up of the participants will be determined by the treating physicians according to her/his routine practice.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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