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

Takeda

Status: Enrolling

Conditions: Acquired Hemophilia A

Treatments: Drug: OBIZUR

Study type: Observational

Funder types: Industry

Identifiers

NCT06550882

TAK-672-4002

Details and patient eligibility

About

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.

Full description

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

Enrollment: 9 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

9 participants in 1 patient group

All Participants

Description:

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.

Treatment:

Drug: OBIZUR