Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
NCT ID: NCT03008616
Last Updated: 2022-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
59 participants
INTERVENTIONAL
2017-04-12
2020-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AMAG-423 (digoxin immune fab)
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
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
Placebo
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treated with expectant management
* Meets modified ACOG criteria for severe preeclampsia
* Willing and able to provide written, informed consent
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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AMAG Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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AMAG-423-201
Identifier Type: -
Identifier Source: org_study_id
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