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

Phase 2

Terminated

• Conditions: Severe Preeclampsia
• Interventions: Other: Placebo; Biological: AMAG-423 (digoxin immune fab)

• Registration Number: NCT03008616
• Lead Sponsor: AMAG Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-29
• Study First Posted: 2017-01-02
• Study Start: 2017-04-12
• Primary Completion: 2020-08-13
• Study Completion: 2020-08-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 59

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal saline, 30 minute IV infusion, every 6 hours x 4 days
AMAG-423 (digoxin immune fab)	AMAG-423 (digoxin immune fab)	AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days

Primary Outcome Measures

Name	Time	Method
Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age	36 weeks corrected gestational age	Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age

Secondary Outcome Measures

Name	Time	Method
Change from baseline in serum creatinine	From treatment initiation to 24 hours post first dose	Maternal change from baseline in serum creatinine to 24 hours post first dose
Incidence of pulmonary edema	From treatment initiation until completion of treatment phase (up to 4 days)	Maternal incidence of pulmonary edema during the treatment period
Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post first dose	24 hours post first dose	Proportion of mothers with modified early obstetric warning score \>= 3 at 24 hours post final dose
Delivery latency	From treatment initiation until delivery	Time from start of treatment until delivery
Anti-hypertensive use during treatment	From treatment initiation until completion of treatment phase (up to 4 days)	Use of or change in anti-hypertensive use during the treatment period

Trial Locations

Locations (18)

University of South Alabama; 🇺🇸 Mobile, Alabama, 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

Detroit Medical Center (DMC); 🇺🇸 Detroit, Michigan, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Louisiana State University Health Sciences Center in New Orleans; 🇺🇸 New Orleans, Louisiana, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Adalbertus Hospital; 🇵🇱 Gdansk, Pomorskie, Poland

University Of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Children's Hospital Foundation Building; 🇺🇸 Louisville, Kentucky, 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

Sefako Makgatho Health Sciences University; 🇿🇦 Pretoria, Gauteng, South Africa

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States