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

Not yet recruiting

Conditions: Acquired Hemophilia A

Registration Number: NCT06550882

Lead Sponsor: Takeda

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 9

Inclusion 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI);Number of Participants With Expected/Unexpected AEs and SAEs;Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs;Number of Participants With Special Situation Report (SSR)

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Overall Bleeding Control;Time to Achieve Bleeding Control With OBIZUR Injection;Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control;Dose of OBIZUR Required to Stop the Bleeding;Percentage of Participants With Bleeding Events