RecruitingPhase 4NCT07157423

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


Sponsor

Novo Nordisk A/S

Enrollment

64 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Eptacog alfa (NovoSeven) for people with severe postpartum haemorrhage. The study is currently recruiting participants at 8 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEptacog alfa (NovoSeven)

Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven)


Locations(10)

KLE Belgum

Belagavi, Karnataka, India

Calicut Medical College

Kozhikode, Kerala, India

Calicut Medical College

Kozhikode, Kerala, India

Seth GS Medical College & KEM Hospital

Mumbai, Maharashtra, India

All India Institute of Medical Sciences_New Dehli

New Delhi, National Capital Territory of Delhi, India

SMS Hospital

Jaipur, Rajasthan, India

SMS Hospital

Jaipur, Rajasthan, India

KLE Belgum

Belagavi, India

Post Graduate Institute of Medical Education & Research_Chandigarh

Chandigarh, India

Post Graduate Institute of Medical Education & Research_Chandigarh

Chandigarh, India

View Full Details on ClinicalTrials.gov

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NCT07157423