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

Severe Preeclampsia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03008616
• Other study ID #: AMAG-423-201
• Status: Terminated
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Severe Preeclampsia

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)