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

NCT07157423 | Recruiting Phase 4

• 2 other identifiers: NN7711-7717U1111-1289-2568
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 8

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of thromboembolic events

  Measured as number of events

  From baseline (day 0) to end of study (day 30)

Secondary Outcomes (4)

• Number of serious adverse events

  From baseline (day 0) to end of study (day 30)

• Number of allergic reactions

  From baseline (day 0) to end of study (day 30)

• All medication errors

  Baseline (day 0)

• Near medication errors

  Baseline (day 0)

Study Arms (1)

Eptacog alfa (NovoSeven)

EXPERIMENTAL

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

Drug: Eptacog alfa (NovoSeven)

Interventions

Eptacog alfa (NovoSeven) DRUG

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

Eptacog alfa (NovoSeven)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (8)

KLE Belgum

Belagavi, Karnataka, 590010, India

RECRUITING

Calicut Medical College

Kozhikode, Kerala, 673008, India

RECRUITING

Calicut Medical College

Kozhikode, Kerala, 673008, India

NOT YET RECRUITING

Seth GS Medical College & KEM Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

All India Institute of Medical Sciences_New Dehli

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

SMS Hospital

Jaipur, Rajasthan, 302004, India

NOT YET RECRUITING

KLE Belgum

Belagavi, 590010, India

NOT YET RECRUITING

Post Graduate Institute of Medical Education & Research_Chandigarh

Chandigarh, 160012, India

NOT YET RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

recombinant FVIIa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 5, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): March 26, 2027
• Study Completion (Estimated): March 26, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IN (8)