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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Severe Preeclampsia

In brief

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.

Key facts

Study ID

NCT03008616

Run by

AMAG Pharmaceuticals, Inc.

People needed

58

Starts

2017-04-12

Expected to finish

2020-08-13

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Children's Hospital Foundation Building — Louisville, Kentucky, United States
• Louisiana State University Health Sciences Center in New Orleans — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Detroit Medical Center (DMC) — Detroit, Michigan, United States
• University Of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• University Hospitals Case Medical Center-Case Western Reserve University (CWRU) — Cleveland, Ohio, United States
• Regional Obstetrical Consultants — Chattanooga, Tennessee, United States
• The University of Texas Medical Branch (UTMB) — Galveston, Texas, United States
• Texas Children's Hospital/Baylor College of Medicine — Houston, Texas, United States
• The University of Texas Health Science Center at Houston (UTHSC-H) — Houston, Texas, United States
• Baylor Scott & White Health — Temple, Texas, United States
• University of Virginia School Of Medicine — Charlottesville, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Adalbertus Hospital — Gdansk, Pomeranian Voivodeship, Poland
• Sefako Makgatho Health Sciences University — Pretoria, Gauteng, South Africa

Full record on ClinicalTrials.gov

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