Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
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| ClinicalTrials.gov Identifier: NCT03008616 |
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Recruitment Status :
Terminated
(Following a recommendation from the Data and Safety Monitoring Board (DSMB), the study was stopped early for futility. There were no safety concerns raised.)
First Posted : January 2, 2017
Last Update Posted : September 3, 2020
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Sponsor:
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Severe Preeclampsia | Biological: AMAG-423 (digoxin immune fab) Other: Placebo | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 59 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | April 12, 2017 |
| Actual Primary Completion Date : | August 13, 2020 |
| Actual Study Completion Date : | August 13, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: AMAG-423 (digoxin immune fab)
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
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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 Name: DigiFab |
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Placebo Comparator: Placebo
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
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Other: Placebo
Normal saline, 30 minute IV infusion, every 6 hours x 4 days |
Primary Outcome Measures :
- Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age [ Time Frame: 36 weeks corrected gestational age ]Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
Secondary Outcome Measures :
- Change from baseline in serum creatinine [ Time Frame: From treatment initiation to 24 hours post first dose ]Maternal change from baseline in serum creatinine to 24 hours post first dose
- Incidence of pulmonary edema [ Time Frame: From treatment initiation until completion of treatment phase (up to 4 days) ]Maternal incidence of pulmonary edema during the treatment period
- Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post first dose [ Time Frame: 24 hours post first dose ]Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post final dose
- Delivery latency [ Time Frame: From treatment initiation until delivery ]Time from start of treatment until delivery
- Anti-hypertensive use during treatment [ Time Frame: From treatment initiation until completion of treatment phase (up to 4 days) ]Use of or change in anti-hypertensive use during the treatment period
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008616
Locations
Show 18 study locations
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
| Responsible Party: | AMAG Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT03008616 |
| Other Study ID Numbers: |
AMAG-423-201 |
| First Posted: | January 2, 2017 Key Record Dates |
| Last Update Posted: | September 3, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Digoxin Anti-Arrhythmia Agents |
Cardiotonic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |