Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
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
- Severe Preeclampsia
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
| Arm | Description | Assigned 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 |
|
|
Placebo Comparator Placebo |
Normal saline, 30 minute IV infusion, every 6 hours x 4 days |
|
More Details
- Status
- Terminated
- Sponsor
- AMAG Pharmaceuticals, Inc.