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

NCT03008616 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AMAG-423-201
• Study Type: interventional
• Target: 58
• Locations: 3 countries
• Sites: 18

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.

Conditions

Severe Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in Serum Creatinine

  From treatment initiation to 24 hours post first dose

• Incidence of Pulmonary Edema

  From treatment initiation until completion of treatment phase (up to 4 days)

Study Arms (2)

AMAG-423 (digoxin immune fab)

ACTIVE COMPARATOR

AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days

Biological: AMAG-423 (digoxin immune fab)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

AMAG-423 (digoxin immune fab) BIOLOGICAL

AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days

Also known as: DigiFab

AMAG-423 (digoxin immune fab)

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead

Study Sites (18)

University of South Alabama

Mobile, Alabama, 36604, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Children's Hospital Foundation Building

Louisville, Kentucky, 40202, United States

Location

Louisiana State University Health Sciences Center in New Orleans

New Orleans, Louisiana, 70112, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Detroit Medical Center (DMC)

Detroit, Michigan, 48201, United States

Location

University Of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center-Case Western Reserve University (CWRU)

Cleveland, Ohio, 44106, United States

Location

Regional Obstetrical Consultants

Chattanooga, Tennessee, 37403, United States

Location

The University of Texas Medical Branch (UTMB)

Galveston, Texas, 77555, United States

Location

Texas Children's Hospital/Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at Houston (UTHSC-H)

Houston, Texas, 77303, United States

Location

Baylor Scott & White Health

Temple, Texas, 76508, United States

Location

University of Virginia School Of Medicine

Charlottesville, Virginia, 29208, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Adalbertus Hospital

Gdansk, Pomeranian Voivodeship, 80-462, Poland

Location

Sefako Makgatho Health Sciences University

Pretoria, Gauteng, 0204, South Africa

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

digoxin antibodies Fab fragments

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Clinical Trial Interest
• Organization: Covis Pharma

CTInterest@covispharma.com

1-877-374-4177

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 2, 2017
• Study Start: April 12, 2017
• Primary Completion: August 13, 2020
• Study Completion: August 13, 2020
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (16); PL (1); ZA (1)