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

AMAG Pharmaceuticals

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Severe Preeclampsia

Treatments: Biological: AMAG-423 (digoxin immune fab); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03008616

AMAG-423-201

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups, including a placebo group

AMAG-423 (digoxin immune fab)

Active Comparator group

Description:

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

Treatment:

Biological: AMAG-423 (digoxin immune fab)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo