NCT07157423

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

Safety of Eptacog Alfa in Severe Postpartum Haemorrhage in India: A Phase IV Interventional Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Postpartum Haemorrhage

Interventions

Type	Name	Description
DRUG	Eptacog alfa (NovoSeven)	Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven)

Timeline

• Start date: 2025-08-26
• Primary completion: 2027-03-26
• Completion: 2027-03-26
• First posted: 2025-09-05
• Last updated: 2026-03-27

Locations

8 sites across 1 country: India