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A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India

StatusRecruiting
PhasePhase 4
Started2025-08-26
View on ClinicalTrials.gov ↗
This study will look at how safe is the medicine eptacog alfa when used in women in India for stopping heavy bleeding after giving birth. If participants have heavy bleeding after giving birth then they will get the medicine eptacog alfa. This study will be conducted to get more knowledge on the safety of the medicine eptacog alfa use in these women. At first participants will receive one dose of medicine eptacog alfa. If the given dose is not helpful to stop the bleeding, participants will get one additional dose. The study will last for about 30-35 days.

Amendment history 3 changes detected by DataLookout

2026-08-14
Trial sites expanded: 10 → 14 locations
2026-08-14
Primary completion pushed: 2027-03-26 → 2027-08-26
2026-08-14
Completion pushed: 2027-03-26 → 2027-08-26
Trial Details
NCT Number NCT07157423
Lead Sponsor Novo Nordisk A/S
Conditions Severe Postpartum Haemorrhage
Enrollment 64 participants
Start Date 2025-08-26
Primary Completion 2027-08-26 (estimated)
Study Completion 2027-08-26 (estimated)
Updated on ClinicalTrials.gov 2026-08-13