Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
AMAG-423 (digoxin immune fab)
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)
    AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
    Other names:
    • DigiFab
Placebo Comparator
Placebo
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
  • Other: Placebo
    Normal saline, 30 minute IV infusion, every 6 hours x 4 days

Recruiting Locations

The University of Texas Medical Branch (UTMB)
Galveston, Texas 77555

More Details

NCT ID
NCT03008616
Status
Recruiting
Sponsor
AMAG Pharmaceuticals, Inc.

Study Contact

Clinical Trial Interest
1-877-233-4781
AMAGCT@druginfo.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.