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Recruiting NCT06550882

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

— Observational Acquired Hemophilia A

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OBIZUR.
Who it may be relevant to
Registry conditions: Acquired Hemophilia A. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug OBIZUR
    OBIZUR injection.

Primary outcome measures

  • Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI) [Time frame: Up to 3 months]
  • Number of Participants With Expected/Unexpected AEs and SAEs [Time frame: Up to 3 months]
  • Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs [Time frame: Up to 3 months]
  • Number of Participants With Special Situation Report (SSR) [Time frame: Up to 3 months]
Secondary outcome measures (5)
  • Percentage of Participants With Overall Bleeding Control [Time frame: Up to 3 months]
  • Time to Achieve Bleeding Control With OBIZUR Injection [Time frame: Up to 3 months]
  • Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control [Time frame: Up to 3 months]
  • Dose of OBIZUR Required to Stop the Bleeding [Time frame: Up to 3 months]
  • Percentage of Participants With Bleeding Events [Time frame: Up to 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 4 centers
  • Kyung Hee University Hospital at Gangdong — Seoul
  • The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul
  • Ewha Womans University Medical Center — Seoul
  • Ulsan University Hospital — Ulsan

Identifiers

NCT: NCT06550882 · TAK-672-4002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗