Study 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 of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
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
1 other identifier
interventional
59
3 countries
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2017
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2016
CompletedFirst Posted
Study publicly available on registry
January 2, 2017
CompletedStudy Start
First participant enrolled
April 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2020
CompletedApril 4, 2022
March 1, 2022
3.3 years
December 20, 2016
March 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
36 weeks corrected gestational age
Secondary Outcomes (5)
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)
Study Arms (2)
AMAG-423 (digoxin immune fab)
ACTIVE COMPARATORAMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
Placebo
PLACEBO COMPARATORNormal saline, 30 minute IV infusion, every 6 hours x 4 days
Interventions
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University of South Alabama
Mobile, Alabama, 36604, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Children's Hospital Foundation Building
Louisville, Kentucky, 40202, United States
Louisiana State University Health Sciences Center in New Orleans
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Detroit Medical Center (DMC)
Detroit, Michigan, 48201, United States
University Of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
University Hospitals Case Medical Center-Case Western Reserve University (CWRU)
Cleveland, Ohio, 44106, United States
Regional Obstetrical Consultants
Chattanooga, Tennessee, 37403, United States
The University of Texas Medical Branch (UTMB)
Galveston, Texas, 77555, United States
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston (UTHSC-H)
Houston, Texas, 77303, United States
Baylor Scott & White Health
Temple, Texas, 76508, United States
University of Virginia School Of Medicine
Charlottesville, Virginia, 29208, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Adalbertus Hospital
Gdansk, Pomeranian Voivodeship, 80-462, Poland
Sefako Makgatho Health Sciences University
Pretoria, Gauteng, 0204, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2016
First Posted
January 2, 2017
Study Start
April 12, 2017
Primary Completion
August 13, 2020
Study Completion
August 13, 2020
Last Updated
April 4, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share