NCT03008616TerminatedPhase 2
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
AMAG Pharmaceuticals, Inc.36 sites in 3 countries58 target enrollmentStarted: April 12, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- AMAG Pharmaceuticals, Inc.
- Enrollment
- 58
- Locations
- 36
- Primary Endpoint
- Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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
Intervention: AMAG-423 (digoxin immune fab) (Biological)
Placebo
Placebo Comparator
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
Time Frame: 36 weeks corrected gestational age
Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
Secondary Outcomes
- 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))
- Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post first dose(24 hours post first dose)
- Delivery latency(From treatment initiation until delivery)
- Anti-hypertensive use during treatment(From treatment initiation until completion of treatment phase (up to 4 days))
Investigators
Study Sites (36)
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