drugset / Trial / NCT03008616

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

NCT03008616 ↗

Phase 2/3 Terminated 58 enrolled AMAG Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2017-04-12
Primary completion
2020-08-13
Completion
2020-08-13

Outcome

Outcome not reported

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.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator AMAG-423 Unknown 3.2 mg/kg Intravenous

Indications