Clinical trial NCT03008616: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Severe Preeclampsia
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-02
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
timeFrame: 36 weeks corrected gestational age
Secondary outcomes:
measure: Change from baseline in serum creatinine
timeFrame: From treatment initiation to 24 hours post first dose
measure: Incidence of pulmonary edema
timeFrame: From treatment initiation until completion of treatment phase (up to 4 days)
measure: Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post first dose
timeFrame: 24 hours post first dose
measure: Delivery latency
timeFrame: From treatment initiation until delivery
measure: Anti-hypertensive use during treatment
timeFrame: From treatment initiation until completion of treatment phase (up to 4 days)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Children's Hospital Foundation Building
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center in New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Detroit Medical Center (DMC)
state: Michigan
city: Jackson
country: United States
facility: University Of Mississippi Medical Center
state: Mississippi
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center-Case Western Reserve University (CWRU)
state: Ohio
city: Chattanooga
country: United States
facility: Regional Obstetrical Consultants
state: Tennessee
city: Galveston
country: United States
facility: The University of Texas Medical Branch (UTMB)
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital/Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston (UTHSC-H)
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Health
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia School Of Medicine
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Gdansk
country: Poland
facility: Adalbertus Hospital
state: Pomorskie
city: Pretoria
country: South Africa
facility: Sefako Makgatho Health Sciences University
state: Gauteng
Study officials:
References: