A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of DigiFab® in Antepartum Subjects With Severe
Phase of Trial: Phase II/III
Latest Information Update: 21 Sep 2017
At a glance
- Drugs Anti-digoxin polyclonal antibody (Primary)
- Indications Preeclampsia
- Focus Registrational; Therapeutic Use
- Sponsors Velo Bio
- 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.