University of Texas Medical Branch

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

Purpose

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.

Condition

Severe Preeclampsia

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: Female
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator AMAG-423 (digoxin immune fab)	AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days	Biological: AMAG-423 (digoxin immune fab) AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days Other names: DigiFab
Placebo Comparator Placebo	Normal saline, 30 minute IV infusion, every 6 hours x 4 days	Other: Placebo Normal saline, 30 minute IV infusion, every 6 hours x 4 days

More Details

Status: Terminated
Sponsor: AMAG Pharmaceuticals, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.