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

Novo Nordisk

Status and phase

Enrolling

Phase 4

Conditions

Severe Postpartum Haemorrhage

Treatments

Drug: Eptacog alfa (NovoSeven)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07157423

NN7711-7717

U1111-1289-2568 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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