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

NCT06550882 | Recruiting FDA Drug

• 1 other identifier: TAK-672-4002
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Hemophilia A

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Percentage of Participants With Overall Bleeding Control

  Up to 3 months

• Time to Achieve Bleeding Control With OBIZUR Injection

  Up to 3 months

• Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control

  Up to 3 months

• Dose of OBIZUR Required to Stop the Bleeding

  Up to 3 months

• Percentage of Participants With Bleeding Events

  Up to 3 months

Study Arms (1)

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

Interventions

OBIZUR DRUG

OBIZUR injection.

Also known as: Susoctocog Alpha, Porcine Antihemophilic factor VIII, Recombinant, TAK-672

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

RECRUITING

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Factor 8 deficiency, acquired

Interventions

Factor VIII

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: July 22, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

KR (1)