Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | April 12, 2017 |
| End Date: | September 2020 |
| Contact: | Clinical Trial Interest |
| Email: | AMAGCT@druginfo.com |
| Phone: | 1-877-233-4781 |
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
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.
management in the treatment of severe preeclampsia as compared to placebo.
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
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