Trial | NCT03008616  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    59
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.
Study Started
Apr 12
2017
Primary Completion
Aug 13
2020
Study Completion
Aug 13
2020
Last Update
Apr 04
2022

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

Other Placebo

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

Placebo Placebo Comparator

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

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

Criteria 

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
No Results Posted