A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of DigiFab® in Antepartum Subjects With Severe

Trial Profile

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of DigiFab® in Antepartum Subjects With Severe

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Anti-digoxin polyclonal antibody (Primary)
  • Indications Preeclampsia
  • Focus Registrational; Therapeutic Use
  • Sponsors Velo Bio
  • Most Recent Events

    • 01 Jun 2017 According to an AMAG Pharmaceuticals media release, first patient has been enrolled in the trial.
    • 01 Jun 2017 According to an AMAG Pharmaceuticals media release, results of this study may form the basis for a new drug application (NDA) with potential approval of DIF by the U.S. Food and Drug Administration (FDA) in 2020, assuming a submission in 2019.
    • 11 Apr 2017 Status changed from not yet recruiting to recruiting.
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