Trials / Terminated
TerminatedNCT03008616
Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
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
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- AMAG Pharmaceuticals, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AMAG-423 (digoxin immune fab) | AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days |
| OTHER | Placebo | Normal saline, 30 minute IV infusion, every 6 hours x 4 days |
Timeline
- Start date
- 2017-04-12
- Primary completion
- 2020-08-13
- Completion
- 2020-08-13
- First posted
- 2017-01-02
- Last updated
- 2022-04-04
Locations
18 sites across 3 countries: United States, Poland, South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03008616. Inclusion in this directory is not an endorsement.