Clinical Trial Results:
A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients with Congenital Hemophilia A or B with Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures
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Summary
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EudraCT number |
2022-004132-25 |
Trial protocol |
Outside EU/EEA |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Apr 2026
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First version publication date |
16 Apr 2026
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Other versions |
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Summary report(s) |
CSR synopsis F7TG2202 final V1.0 02Dec2025 |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.