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Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
Sponsor: AMAG Pharmaceuticals, Inc.
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.
Official 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2017-04-12
Completion Date
2020-08-13
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
AMAG-423 (digoxin immune fab)
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
Placebo
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Locations (18)
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