AMAG-423-201_Antepartum Pts with Severe preeclampsia taking AMAG-423
Research type
Research Study
Full title
A Phase 2b/3a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of AMAG-423, a Digoxin Immune Fab, in Antepartum Subjects with Severe Preeclampsia
IRAS ID
265222
Contact name
Paul Ayuk
Contact email
Sponsor organisation
AMAG Pharmaceuticals, Inc.
Eudract number
2018-004212-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
Preeclampsia (PE) is a disease involving the development of high blood pressure with a high quantity of protein in the urine and/or swelling due to fluid build up in tissue of the body due to pregnancy or the influence of a recent pregnancy. The symptoms can be life-threatening to both Mother and baby. Preeclampsia is a leading cause of maternal and perinatal (immediately before and after birth) mortality and morbidity worldwide.
In most cases of severe preeclampsia, the baby is delivered early to protect the Mother and the baby. However, even with the best care, babies of Mothers with preeclampsia may also have serious and lasting medical conditions. It is not known why preeclampsia occurs but it's thought that “digoxin-like substances” which circulate in the blood may be one of the causes.
DigiFab® [Digoxin Immune Fab (Ovine)] is approved in the US and in the UK to treat toxic levels of digoxin. As Digoxin Immune Fab is being evaluated as a potential treatment for severe preeclampsia by AMAG Pharmaceuticals Inc. it will be referred to as AMAG-423 in this study.
200 women 18yrs or older at up to 90 Hospitals globally will take part. Half of the patients will receive AMAG-423 & the other half placebo. All study patients will continue to receive all medications and treatment considered standard of care.
After signed consent, maternal assessments are physical exam, vital signs, lab assessments, monitoring preeclampsia symptoms and Electrocardiogram. Infant assessments are cranial ultrasound, foetal heart rate, physical exam and lab tests.
Study treatment will last up to 4 days for the Mother. Study drug will be given through a fluid line in the vein every 6 hrs. There will be a follow up period at 6 wks post-partum for the Mom and for the baby until wk 36 of their corrected gestational age.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0207
Date of REC Opinion
29 Aug 2019
REC opinion
Further Information Favourable Opinion