OBIZUR treatment for adults with acquired hemophilia A 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
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 |
|---|---|
| Enrollment | 9 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06550882 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul
- Kyung Hee University Hospital at Gangdong — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.