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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Severe Preeclampsia

Intervention / Treatment
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* Biological: AMAG-423 (digoxin immune fab)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AMAG-423 (digoxin immune fab)<br>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)<br>* AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days<br>* Other names: DigiFab;|
| Placebo Comparator: Placebo<br>Normal saline, 30 minute IV infusion, every 6 hours x 4 days | Other: Placebo<br>* Normal saline, 30 minute IV infusion, every 6 hours x 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 
| 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 | 
| Delivery latency | Time from start of treatment until delivery | From treatment initiation until delivery | 
| 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) |