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

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.

Study Overview

• Status: Recruiting
• Conditions: Acquired Hemophilia A
• Intervention / Treatment: Drug: OBIZUR

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 9

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• South Korea
  • Seoul, South Korea, 06591
    • Recruiting
    • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Contact: Site Contact; Phone Number: +82-2-2258-5745; Email: royoon@catholic.ac.kr
    • Principal Investigator: Jae-ho Yoon
  • Seoul, South Korea, 05278
    • Recruiting
    • Kyung Hee University Hospital at Gangdong
    • Contact: Site contact; Email: pysped@khu.ac.kr
    • Principal Investigator: Young Shil Park, Ph.D
  • Seoul, South Korea, 07804
    • Recruiting
    • Ewha Womans University Medical Center
    • Contact: Site Contact; Phone Number: +82-2-6986-3100; Email: anemia@khu.ac.kr
    • Principal Investigator: Jae-joon Han
  • Ulsan, South Korea, 44033
    • Recruiting
    • Ulsan University Hospital
    • Principal Investigator: Yoo Jin Lee
    • Contact: Site Contact; Phone Number: +82-52-250-7000; Email: yjleeh@uuh.ulsan.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: OBIZUR; OBIZUR injection.; Other Names: TAK-672; Susoctocog Alpha; Porcine Antihemophilic factor VIII, Recombinant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)	Number of participants with AEs, causality to AEs, SAEs and AESI will be reported. The investigator will assess the causal relationship (causality) between the medicinal product and the AE using his/her clinical expertise and judgment.	Up to 3 months
Number of Participants With Expected/Unexpected AEs and SAEs	Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.	Up to 3 months
Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs	An ADR refers to any undesirable and unintended reaction which occurs during or following the administration of the drug, and in which a causal relationship with the drug cannot be ruled out. In the event that a causal relationship with the drug remains unknown amongst reported adverse events, such reaction shall be considered an adverse drug reaction. Serious ADR means noxious or unintended response to a drug that occurs at any dosage and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Unexpected ADRs is defined as ADR that differs from the information in the product label in nature, severity, specificity, or outcome.	Up to 3 months
Number of Participants With Special Situation Report (SSR)	SSR include following events: Pregnancy: any case in which a pregnancy participant is exposed to a Takeda Product or in which a female participant or partner of a male participant becomes pregnant following Takeda product.; Breastfeeding: infant exposure from breast milk; Overdose: all information of any accidental or intentional overdose; Drug abuse, misuse or medication error: all information on medicinal product (MP) abuse, misuse of medication error (potential or actual); Suspected transmission of infectious agent: Suspected (in sense of confirmed or potential) transmission of infectious agent by a MP; Lack of efficacy of Takeda Product; accidental/occupational exposure; Use outside the terms of the marketing authorization, also known as "off-label" and "off-label use"; Use of falsified and counterfeit MP; Drug-drug and drug-food interactions; Inadvertent or accidental exposure with or without an AE; Unintended benefit.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Overall Bleeding Control	Overall Bleeding Control will be determined as either bleeding stopped or did not stop.	Up to 3 months
Time to Achieve Bleeding Control With OBIZUR Injection	Time to achieve bleeding control will be assessed from initiation of OBIZUR Injection (start time) to the time to achieve bleeding control (stop time).	Up to 3 months
Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control	Number of OBIZUR injection infusion required to achieve bleeding control will be reported.	Up to 3 months
Dose of OBIZUR Required to Stop the Bleeding	OBIZUR dose required to stop the bleeding will be reported.	Up to 3 months
Percentage of Participants With Bleeding Events	Bleeding events will be evaluated and reported as re-bleed, concurrent bleed and subsequent bleed. Re-bleed: if it occurs in the same anatomical location and within 72 hours of the resolution of the previous bleeding. Concurrent bleed: if it occurs at the same time (that is, during treatment or within 72 hours of resolution) as previous bleed but at a different anatomical location. Subsequent bleed: if it is a new bleed occurring 72 hours after the resolution of the previous bleed (either in the same anatomical location or in a new one).	Up to 3 months

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.
• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Factor 8 deficiency, acquired; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Blood Proteins; Blood Coagulation Factors; Protein Precursors; Factor VIII
• Other Study ID Numbers: TAK-672-4002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes