Actively Recruiting
Post-Marketing Surveillance of OBIZUR Injection for Acquired Hemophilia A Treatment in South Korea
Led by Takeda · Updated on 2026-05-19
9
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with Acquired Hemophilia A (AHA), a rare bleeding disorder where blood does not clot properly, leading to sudden and severe bleeding. This study aims to evaluate the safety of OBIZUR injection in adults with AHA and to observe how the treatment controls bleeding in real-world clinical settings. The study collects both past and ongoing data from participants receiving OBIZUR as part of their routine care. This is a single-arm, observational study involving participants who are either currently receiving OBIZUR or are starting OBIZUR treatment for the first time. Data will be collected retrospectively from the first OBIZUR treatment after approval in Korea and prospectively from the time participants consent to join the study. Treatment decisions and follow-up care are managed by the treating physicians according to standard practice. Participants will have their existing medical records reviewed, and new health information will be collected during the study. Researchers will monitor adverse events, bleeding control effectiveness, and treatment usage over approximately three months. The study focuses on safety outcomes such as adverse events and drug reactions, as well as measures of bleeding control like time and dose needed to stop bleeding. The total participation time varies based on each patient's routine care and treatment schedule.
CONDITIONS
Brief Title
A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with Acquired Hemophilia A (AHA)
- Participants who need OBIZUR treatment as determined by their doctor
- Participants aged 18 years or older at the start of OBIZUR treatment
- Participants who agree to join the study and sign informed consent
You will not qualify if you...
- Participants allergic to OBIZUR or any of its ingredients
- Participants with Congenital Hemophilia A with Inhibitors (CHAWI)
- Participants for whom OBIZUR treatment is not allowed according to product guidelines
- Participants who have joined another clinical study with a drug or device within 30 days before joining or plan to do so during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive OBIZUR injections as part of their routine care for Acquired Hemophilia A, with treatment and follow-up determined by their physician's usual practice.
Visits as determined by treating physician according to routine practice
Duration - Up to 3 months
Participants are monitored for adverse events and bleeding control outcomes after treatment with OBIZUR.
Visits as determined by treating physician according to routine practice
Trial Site Locations
Total: 4 locations
1
Kyung Hee University Hospital at Gangdong
Seoul, South Korea, 05278
Actively Recruiting
2
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
3
Ewha Womans University Medical Center
Seoul, South Korea, 07804
Actively Recruiting
4
Ulsan University Hospital
Ulsan, South Korea, 44033
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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