Survey of a treatment for Acquired Hemophilia A
General Use-results Survey of OBIZER for I.V. Injection (All-case Surveillance)
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Tokyo, Tokyo) |
| Trial ID | NCT06461533 on ClinicalTrials.gov |
What this trial studies
This observational study surveys the use of Susoctocog Alfa (Genetical Recombination) intravenous injection in participants with Acquired Hemophilia A in Japan. The study aims to monitor side effects and assess the effectiveness of the treatment in improving bleeding events. Participants will receive the treatment according to their clinic's standard practice, and the study will track outcomes for up to 90 days post-treatment. The sponsor will provide guidelines for clinics on how to document the treatment process and results.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Acquired Hemophilia A who are receiving treatment with Susoctocog Alfa.
Not a fit: Patients who do not have Acquired Hemophilia A or are not treated with Susoctocog Alfa will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of Susoctocog Alfa's effectiveness and safety in treating Acquired Hemophilia A.
How similar studies have performed: While this study focuses on a specific treatment, similar observational studies have shown promise in monitoring treatment effects in hemophilia management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- All participants with Acquired Haemophilia A, treated with Susoctocog Alfa (Genetical Recombination). Exclusion Criteria: \- None
Where this trial is running
Tokyo, Tokyo
- Takeda selected site — Tokyo, Tokyo, Japan (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.