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

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ClinicalTrials.gov Identifier: NCT03008616
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Severe Preeclampsia Biological: AMAG-423 (digoxin immune fab) Other: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arms and Interventions
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Arm Intervention/treatment
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
 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 Name: DigiFab
Placebo Comparator: Placebo
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
 Other: Placebo
Normal saline, 30 minute IV infusion, every 6 hours x 4 days


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline in serum creatinine [ Time Frame: From treatment initiation to 24 hours post first dose ]
    Maternal change from baseline in serum creatinine to 24 hours post first dose

  2. Incidence of pulmonary edema [ Time Frame: From treatment initiation until completion of treatment phase (up to 4 days) ]
    Maternal incidence of pulmonary edema during the treatment period

  3. Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post first dose [ Time Frame: 24 hours post first dose ]
    Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post final dose

  4. Delivery latency [ Time Frame: From treatment initiation until delivery ]
    Time from start of treatment until delivery

  5. Anti-hypertensive use during treatment [ Time Frame: From treatment initiation until completion of treatment phase (up to 4 days) ]
    Use of or change in anti-hypertensive use during the treatment period


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008616


Contacts
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Contact: Clinical Trial Interest 1-877-233-4781 AMAGCT@druginfo.com

Locations
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United States, Alabama
University of South Alabama Recruiting
Mobile, Alabama, United States, 36604
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Children's Hospital Foundation Building Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana State University Health Sciences Center in New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
United States, Michigan
Detroit Medical Center (DMC) Recruiting
Detroit, Michigan, United States, 48201
United States, Mississippi
University Of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
University Hospitals Case Medical Center-Case Western Reserve University (CWRU) Recruiting
Cleveland, Ohio, United States, 44106
United States, Tennessee
Regional Obstetrical Consultants Recruiting
Chattanooga, Tennessee, United States, 37403
United States, Texas
The University of Texas Medical Branch (UTMB) Recruiting
Galveston, Texas, United States, 77555
Texas Children's Hospital/Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
The University of Texas Health Science Center at Houston (UTHSC-H) Recruiting
Houston, Texas, United States, 77303
Baylor Scott & White Health Recruiting
Temple, Texas, United States, 76508
United States, Virginia
University of Virginia School Of Medicine Recruiting
Charlottesville, Virginia, United States, 29208
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
More Information
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Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03008616     History of Changes
Other Study ID Numbers: AMAG-423-201
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Digoxin
Immunoglobulin Fab Fragments
Anti-Arrhythmia Agents
 Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Immunologic Factors