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

Primary Purpose

Severe Preeclampsia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AMAG-423 (digoxin immune fab)
Placebo
Sponsored by
AMAG Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Preeclampsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Alabama
  • University of Kansas Medical Center
  • Children's Hospital Foundation Building
  • Louisiana State University Health Sciences Center in New Orleans
  • University of Maryland
  • Detroit Medical Center (DMC)
  • University Of Mississippi Medical Center
  • University of Cincinnati Medical Center
  • University Hospitals Case Medical Center-Case Western Reserve University (CWRU)
  • Regional Obstetrical Consultants
  • The University of Texas Medical Branch (UTMB)
  • Texas Children's Hospital/Baylor College of Medicine
  • The University of Texas Health Science Center at Houston (UTHSC-H)
  • Baylor Scott & White Health
  • University of Virginia School Of Medicine
  • Medical College of Wisconsin
  • Adalbertus Hospital
  • Sefako Makgatho Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AMAG-423 (digoxin immune fab)

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in serum creatinine
Maternal change from baseline in serum creatinine to 24 hours post first dose
Incidence of pulmonary edema
Maternal incidence of pulmonary edema during the treatment period
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
Delivery latency
Time from start of treatment until delivery
Anti-hypertensive use during treatment
Use of or change in anti-hypertensive use during the treatment period

Full Information

First Posted
December 20, 2016
Last Updated
March 31, 2022
Sponsor
AMAG Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03008616
Brief Title
Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Following a recommendation from the Data and Safety Monitoring Board (DSMB), the study was stopped early for futility. There were no safety concerns raised.
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
August 13, 2020 (Actual)
Study Completion Date
August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AMAG Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Preeclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMAG-423 (digoxin immune fab)
Arm Type
Active Comparator
Arm Description
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Intervention Type
Biological
Intervention Name(s)
AMAG-423 (digoxin immune fab)
Other Intervention Name(s)
DigiFab
Intervention Description
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Primary Outcome Measure Information:
Title
Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
Description
Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
Time Frame
36 weeks corrected gestational age
Secondary Outcome Measure Information:
Title
Change from baseline in serum creatinine
Description
Maternal change from baseline in serum creatinine to 24 hours post first dose
Time Frame
From treatment initiation to 24 hours post first dose
Title
Incidence of pulmonary edema
Description
Maternal incidence of pulmonary edema during the treatment period
Time Frame
From treatment initiation until completion of treatment phase (up to 4 days)
Title
Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post first dose
Description
Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post final dose
Time Frame
24 hours post first dose
Title
Delivery latency
Description
Time from start of treatment until delivery
Time Frame
From treatment initiation until delivery
Title
Anti-hypertensive use during treatment
Description
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Children's Hospital Foundation Building
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisiana State University Health Sciences Center in New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Detroit Medical Center (DMC)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University Of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Case Medical Center-Case Western Reserve University (CWRU)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Regional Obstetrical Consultants
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
The University of Texas Medical Branch (UTMB)
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Texas Children's Hospital/Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Houston (UTHSC-H)
City
Houston
State/Province
Texas
ZIP/Postal Code
77303
Country
United States
Facility Name
Baylor Scott & White Health
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Virginia School Of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
29208
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Adalbertus Hospital
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-462
Country
Poland
Facility Name
Sefako Makgatho Health Sciences University
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0204
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

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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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