Open-Label Study of M281 in Pregnant Women at High Risk for HDFN
Research type
Research Study
Full title
A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
IRAS ID
251145
Contact name
Mark Kilby
Contact email
Sponsor organisation
Momenta Pharmaceuticals, Inc.
Eudract number
2017-004958-42
Duration of Study in the UK
4 years, 1 months, 0 days
Research summary
Haemolytic disease of the foetus and newborn (HDFN) is a rare and potentially life-threatening condition in which proteins of the immune system (alloantibodies) from a mother crosses the placenta during pregnancy and damages fetal red blood cells (RBCs) and causes fetal anaemia (low RBCs count). In severe cases, fetal anaemia can result in abnormal fluid build-up in the foetus (fetal hydrops) which if left untreated, may result in stillbirth.
Standard treatment for HDFN after delivery can include a light treatment (phototherapy), blood transfusions, and an injection of a solution of antibodies to prevent RBCs being destroyed.
The study medication in this clinical study, M281 Injection, was developed to avoid the need for surgical intervention for pregnant mothers with history of HDFN onset earlier than 24 weeks in their previous pregnancy, thus increasing their risk for developing HDFN in the current pregnancy.
M281 works by blocking the neonatal Fc receptor (FcRn) which helps to facilitate the transport of the mother's immunoglobulin G (IgG, an infection-fighting molecule) to the growing foetus in pregnant women at high risk HDFN. This blockade of FcRn is intended to reduce the risk and severity of fetal anaemia by reducing the transfer of the mother’ IgG, including pathogens (a germ), to the foetus, and blocks IgG recycling, which therefore reduces pathogens in mother’s blood.
In this research study, approximately 15 pregnant women of 18 years of age or older will participate and all 15 participants will receive M281. The study will involve both the pregnant woman and their babies however, M281 will only be administered the participant and not the baby. After delivery, the baby’s health outcomes and laboratory tests will be assessed. The total time on study will be approximately 12.5 months for the mother and 24 months for the baby.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0390
Date of REC Opinion
21 Dec 2018
REC opinion
Further Information Favourable Opinion