Clinical trial NCT06550882: A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea
Official title: Post-Marketing Surveillance (Use-result Surveillance) of OBIZUR Injection [Susoctocog Alpha (Porcine Antihemophilic Factor VIII, Recombinant)] for the Approved Indications in South Korea
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acquired Hemophilia A
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-08-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with AHA who are receiving OBIZUR Injection or initiate OBIZUR Injection treatment for the first time will be enrolled.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
timeFrame: Up to 3 months
measure: Number of Participants With Expected/Unexpected AEs and SAEs
timeFrame: Up to 3 months
measure: Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs
timeFrame: Up to 3 months
measure: Number of Participants With Special Situation Report (SSR)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Percentage of Participants With Overall Bleeding Control
timeFrame: Up to 3 months
measure: Time to Achieve Bleeding Control With OBIZUR Injection
timeFrame: Up to 3 months
measure: Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control
timeFrame: Up to 3 months
measure: Dose of OBIZUR Required to Stop the Bleeding
timeFrame: Up to 3 months
measure: Percentage of Participants With Bleeding Events
timeFrame: Up to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: