RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - Participants with hypersensitivity to any of the components of this drug. - Participants with Congenital Hemophilia A with Inhibitors (CHAWI). - Participants for whom Obizur treatment is contraindicated as per product label. - Participants who has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * Participants with hypersensitivity to any of the components of this drug. * Participants with Congenital Hemophilia A with Inhibitors (CHAWI). * Participants for whom Obizur treatment is contraindicated as per product label. * Participants who has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of the study.

Treatments Being Tested

DRUG

OBIZUR

OBIZUR injection.

Locations (1)

Kyung Hee University Hospital at Gangdong

Seoul, South Korea