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Safety Study of Eptacog Alfa to Stop Severe Bleeding After Childbirth in Adult Women in India
Led by Novo Nordisk A/S · Updated on 2026-06-12
64
Participants Needed
10
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the safety of the medicine eptacog alfa in women in India who experience severe heavy bleeding after giving birth. The study focuses on women aged 18 years and older who have severe postpartum hemorrhage that does not respond to uterotonics. The purpose is to gain more knowledge about how safe eptacog alfa is when used in these situations. Participants will receive one intravenous bolus injection of eptacog alfa. If the first dose does not stop the bleeding, a second dose may be given. This study is a phase IV interventional trial with a single treatment group. The total study duration for each participant will be about 30 to 35 days. During the study, participants will be monitored for any thromboembolic events, serious adverse events, allergic reactions, and medication errors from baseline through day 30. Safety assessments and follow-ups will be conducted to track these outcomes. The studys lead sponsor is Novo Nordisk AS, and it includes careful observation from the time of treatment through the end of the study period.
CONDITIONS
Brief Title
A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India
Research Team
N
Novo Nordisk
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