TerminatedPhase 2/3

Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia

Stopped: Following a recommendation from the Data and Safety Monitoring Board (DSMB), the study was stopped early for futility. There were no safety concerns raised.

United States, Poland, South Africa58 participantsStarted 2017-04-12

Plain-language summary

This study evaluates the use of AMAG-423 (Digoxin Immune Fab) in addition to expectant management in the treatment of severe preeclampsia as compared to placebo.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Fetal gestational age 23 0/7 to 31 6/7 weeks * Treated with expectant management * Meets modified ACOG criteria for severe preeclampsia * Willing and able to provide written, informed consent Exclusion Criteria: * Decision to deliver within 24 hours has been made * Weight \> 150 kg * Eclampsia * Significant antecedent obstetrical problems * Clinically significant fetal anomaly or chromosomal abnormalities * Chronic renal disease * Active hepatic disease, antiphospholipid antibody syndrome, or lupus * Unstable medical or psychiatric disorder * Need for use of digitalis like products * History of anaphylactic allergic reactions * Prior use of antibodies/fab fragments from sheep * Serum creatinine ≥ 2.0 mg/dL * Platelet count \< 50,000 * Pulmonary edema * Estimated fetal weight \< 5th percentile

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Infants Who Have Severe IVH, NEC, or Death by 36 Weeks Corrected Gestational Age

Timeframe: 36 weeks corrected gestational age

Trial details

NCT IDNCT03008616

SponsorAMAG Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08-13

Results submitted2024-08-09

View on ClinicalTrials.gov More Severe Preeclampsia trials