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

Phase 3TerminatedNCT03008616

AMAG Pharmaceuticals, Inc.59 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Severe Preeclampsia

Interventions

AMAG-423 (digoxin immune fab)BIOLOGICAL

AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days

PlaceboOTHER

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

University of South Alabama

Mobile, Alabama, United States

University of Kansas Medical Center

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

Secondary Outcomes

Change from baseline in serum creatinine

Maternal change from baseline in serum creatinine to 24 hours post first dose

Time frame: From treatment initiation to 24 hours post first dose

Incidence of pulmonary edema

Maternal incidence of pulmonary edema during the treatment period

Time frame: 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

Time frame: 24 hours post first dose

Delivery latency

Time from start of treatment until delivery

Time frame: From treatment initiation until delivery

Anti-hypertensive use during treatment

Use of or change in anti-hypertensive use during the treatment period

Time frame: From treatment initiation until completion of treatment phase (up to 4 days)

Data from ClinicalTrials.gov

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