A clinical study For bleeding prevention treatment with FVIIa/FX in patients with acquired hemophilia A

JRCT ID: jRCT1041240142

Registered date:12/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: aquirwed hemophilia A
• Date of first enrollment: 12/12/2024
• Target sample size: 24
• Study type: Observational

Outcome(s)

• Primary Outcome: Number of bleedings that required treatment during the period of bleeding prevention treatment (annual blood rate)

Secondary Outcome

1)Remission rate and period until remission
2) Changes in clinical test values
3) Activities of daily living (ADL) of research subjects: Changes in Bersal index (BI)
4)Serious adverse events (adverse event name, timing of onset, causal relationship)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients over 20 years old diagnosed with acquired hemophilia A (regardless of gender)
2)Patients who have bleeding tendency and have undergone bleeding treatment with bypass hemostatic products (rFVIIa, aPCC, FVIIa/FX)
3)Patients scheduled to undergo bleeding prevention treatment with emicizumab or FVIIa/FX
4)Patients who have given consent to this study from themselves or their representative

Exclude criteria

1)Patients with bleeding disorders other than acquired hemophilia A
2)Patients not using bypass hemostatic products
3)Patients judged by the research director or co-investigator to be inappropriate for research participation

Related Information

• Primary Sponsor: Matsushita Tadashi
• Source(s) of Monetary Support: KM Biologics.Co.,Ltd