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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03008616
Other study ID # AMAG-423-201
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date April 12, 2017
Est. completion date August 13, 2020

Study information

Verified date March 2022
Source AMAG Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 59
Est. completion date August 13, 2020
Est. primary completion date August 13, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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:
Placebo
Normal saline, 30 minute IV infusion, every 6 hours x 4 days

Locations

Country Name City State
Poland Adalbertus Hospital Gdansk Pomorskie
South Africa Sefako Makgatho Health Sciences University Pretoria Gauteng
United States University of Maryland Baltimore Maryland
United States University of Virginia School Of Medicine Charlottesville Virginia
United States Regional Obstetrical Consultants Chattanooga Tennessee
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 Detroit Medical Center (DMC) Detroit Michigan
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 University Of Mississippi Medical Center Jackson Mississippi
United States University of Kansas Medical Center Kansas City Kansas
United States Children's Hospital Foundation Building Louisville Kentucky
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of South Alabama Mobile Alabama
United States Louisiana State University Health Sciences Center in New Orleans New Orleans Louisiana
United States Baylor Scott & White Health Temple Texas

Sponsors (1)

Lead Sponsor Collaborator
AMAG Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Poland,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age 36 weeks corrected gestational age
Secondary Change from baseline in serum creatinine Maternal change from baseline in serum creatinine to 24 hours post first dose From treatment initiation to 24 hours post first dose
Secondary Incidence of pulmonary edema Maternal incidence of pulmonary edema during the treatment period From treatment initiation until completion of treatment phase (up to 4 days)
Secondary Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post first dose Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post final dose 24 hours post first dose
Secondary Delivery latency Time from start of treatment until delivery From treatment initiation until delivery
Secondary Anti-hypertensive use during treatment Use of or change in anti-hypertensive use during the treatment period From treatment initiation until completion of treatment phase (up to 4 days)
See also
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Not yet recruiting NCT06265415 - Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine N/A
Completed NCT02379832 - Pre-Eclampsia And Growth Restriction: a Longitudinal Study
Not yet recruiting NCT01538121 - Antiphospholipid Antibodies and Early Severe Preeclampsia. N/A
Recruiting NCT01906567 - İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels? N/A
Recruiting NCT01382732 - Carbetocin vs. Oxytocin for Prevention of Postpartum Bleeding in Patients With Severe Preeclampsia Phase 3
Completed NCT01408979 - Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia Phase 4
Completed NCT01538147 - Restless Leg Syndrome and Severe Preeclampsia N/A