OBIZUR treatment for adults with acquired hemophilia A 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
Run by Takeda · NCT06550882 · Data updated 2026-11-12
This project will test how safe OBIZUR is and whether it helps control bleeding in adults in South Korea who have acquired hemophilia A.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 11 (estimated) |
| Sponsor | Takeda Industry-sponsored |
| Locations | 4 sites (Seoul and 3 other locations) |
| Status | Recruiting |
| Started | July 22, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT06550882 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 years or older in South Korea with acquired hemophilia A who are determined by their physician to need OBIZUR treatment and who provide informed consent.
✕Probably not a fit
Patients with congenital hemophilia A with inhibitors, known hypersensitivity to OBIZUR components, or other contraindications per the product label are not expected to benefit from this treatment in the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, single-arm, non-interventional post-marketing surveillance study combining prospective and retrospective data collection. Treatment with OBIZUR is determined by the participants' treating physicians as part of routine clinical care rather than by the study protocol. The study will collect existing medical-record data and new clinical information to describe real-world use patterns, safety events, and bleeding control. Sites in South Korea will enroll adults with acquired hemophilia A who receive OBIZUR in clinical practice.
Why it matters
Potential benefit: If successful, the findings could confirm OBIZUR's safety and real-world effectiveness for controlling bleeding in adults with acquired hemophilia A and support its use in routine care.
How similar studies have gone: Recombinant porcine factor VIII (OBIZUR) has demonstrated efficacy and an acceptable safety profile in previous clinical studies and is used in other countries, so this study is a post-marketing follow-up in routine practice.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Kyung Hee University Hospital at Gangdong
Seoul, South Korea Recruiting -
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea Recruiting -
Ewha Womans University Medical Center
Seoul, South Korea Recruiting -
Ulsan University Hospital
Ulsan, South Korea Recruiting
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Survey of a treatment for Acquired Hemophilia A
This study is trying out a new injection treatment for people with Acquired Hemophilia A in Japan to see if it helps reduce bleeding and what side effects it might have.
-
Observational study of blood clotting and bleeding disorders in Chinese patients
This study looks at blood clotting and bleeding problems in Chinese patients to see how common they are and what factors might affect them.
-
Using a CD38 antibody with corticosteroids to treat acquired hemophilia A
This study is testing if a combination of a new antibody treatment and steroids can help people with acquired hemophilia A stop bleeding and stay healthy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.