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drugset / Trial / NCT07157423

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

NCT07157423 ↗

Phase 4 Recruiting 64 enrolled Novo Nordisk A/S
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-08-26
Primary completion
2027-03-26
Completion
2027-03-26

Drugs

EvaluationDrugModalityDoseRoute
Subject eptacog alfa (activated) Protein / enzyme biologic — Intravenous

Indications

No indication recorded.