Eptacog alfa to stop heavy bleeding after childbirth in India
Safety of Eptacog Alfa in Severe Postpartum Haemorrhage in India: A Phase IV Interventional Study
This will test whether the medicine eptacog alfa can safely stop severe bleeding in women in India after childbirth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 8 sites (Belagavi, Karnataka and 7 other locations) |
| Trial ID | NCT07157423 on ClinicalTrials.gov |
What this trial studies
This Phase 4, multi-center study gives eptacog alfa to adult women in India who develop severe postpartum haemorrhage that does not respond to standard uterotonics. Participants receive one dose of eptacog alfa and, if bleeding continues, may receive a second dose, with monitoring for adverse events. The main focus is on safety, including monitoring for thromboembolic events and other complications, with follow-up lasting about 30–35 days. The study is sponsored by Novo Nordisk and conducted at participating hospitals in Karnataka and Kerala.
Who should consider this trial
Good fit: Adult women (≥18 years) delivering after 27 weeks in India who develop severe postpartum haemorrhage that fails to respond to uterotonics are eligible.
Not a fit: Women with a history of thromboembolism, known bleeding disorders, disseminated intravascular coagulation (DIC), HELLP syndrome, or other listed exclusions are not expected to benefit and are excluded.
Why it matters
Potential benefit: If successful, eptacog alfa could provide an additional option to rapidly control severe postpartum bleeding and reduce related complications.
How similar studies have performed: Use of eptacog alfa for postpartum hemorrhage has been reported in case series and small studies with some success, but results are mixed and concerns about thrombotic risk remain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study except for blood loss estimation post-partum * Adult women aged greater than or equal to (≥) 18 years at the time of signing the informed consent and who deliver after 27 weeks diagnosed with severe postpartum haemorrhage (PPH) who fail to respond to uterotonics Exclusion Criteria: * Previous participation in this study. Participation is defined as having given informed consent in this study * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * Patient with a history of thromboembolism * Patient with a history of bleeding disorders * Patient with a history of or ongoing disseminated intravascular coagulation (DIC); haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome, thrombotic thrombocytopenic purpura (TTP), pre-eclampsia or other severe complication of childbirth apart from severe PPH * Have undergone invasive obstetric procedures for the ongoing haemorrhage prior to trial enrolment (uterine balloon tamponade and external aortic compression not included) * Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise patient's safety or compliance with the protocol * Participation (i.e., signed informed consent) in any other interventional clinical study prior to screening in the current study
Where this trial is running
Belagavi, Karnataka and 7 other locations
- KLE Belgum — Belagavi, Karnataka, India (Recruiting)
- Calicut Medical College — Kozhikode, Kerala, India (Recruiting)
- Calicut Medical College — Kozhikode, Kerala, India (Not_yet_recruiting)
- Seth GS Medical College & KEM Hospital — Mumbai, Maharashtra, India (Recruiting)
- All India Institute of Medical Sciences_New Dehli — New Delhi, National Capital Territory of Delhi, India (Recruiting)
- SMS Hospital — Jaipur, Rajasthan, India (Not_yet_recruiting)
- KLE Belgum — Belagavi, India (Not_yet_recruiting)
- Post Graduate Institute of Medical Education & Research_Chandigarh — Chandigarh, India (Not_yet_recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.