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

NCT03008616 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-05-22

Study results available
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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.

Conditions

  • Severe Preeclampsia

Interventions

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

Placebo

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

Sponsors & Collaborators

  • AMAG Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-12
Primary Completion
2020-08-13
Completion
2020-08-13
FDA Drug
Yes

Countries

  • United States
  • Poland
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03008616 on ClinicalTrials.gov