Severe Preeclampsia Clinical Trial
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
Verified date | March 2022 |
Source | AMAG Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 59 |
Est. completion date | August 13, 2020 |
Est. primary completion date | August 13, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Adalbertus Hospital | Gdansk | Pomorskie |
South Africa | Sefako Makgatho Health Sciences University | Pretoria | Gauteng |
United States | University of Maryland | Baltimore | Maryland |
United States | University of Virginia School Of Medicine | Charlottesville | Virginia |
United States | Regional Obstetrical Consultants | Chattanooga | Tennessee |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | University Hospitals Case Medical Center-Case Western Reserve University (CWRU) | Cleveland | Ohio |
United States | Detroit Medical Center (DMC) | Detroit | Michigan |
United States | The University of Texas Medical Branch (UTMB) | Galveston | Texas |
United States | Texas Children's Hospital/Baylor College of Medicine | Houston | Texas |
United States | The University of Texas Health Science Center at Houston (UTHSC-H) | Houston | Texas |
United States | University Of Mississippi Medical Center | Jackson | Mississippi |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Children's Hospital Foundation Building | Louisville | Kentucky |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of South Alabama | Mobile | Alabama |
United States | Louisiana State University Health Sciences Center in New Orleans | New Orleans | Louisiana |
United States | Baylor Scott & White Health | Temple | Texas |
Lead Sponsor | Collaborator |
---|---|
AMAG Pharmaceuticals, Inc. |
United States, Poland, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change from baseline in serum creatinine | Maternal change from baseline in serum creatinine to 24 hours post first dose | From treatment initiation to 24 hours post first dose | |
Secondary | Incidence of pulmonary edema | Maternal incidence of pulmonary edema during the treatment period | From treatment initiation until completion of treatment phase (up to 4 days) | |
Secondary | 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 | 24 hours post first dose | |
Secondary | Delivery latency | Time from start of treatment until delivery | From treatment initiation until delivery | |
Secondary | Anti-hypertensive use during treatment | Use of or change in anti-hypertensive use during the treatment period | From treatment initiation until completion of treatment phase (up to 4 days) |
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