Trial Outcomes & Findings for Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia (NCT NCT03008616)
NCT ID: NCT03008616
Last Updated: 2026-05-22
Results Overview
Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
58 participants
Primary outcome timeframe
36 weeks corrected gestational age
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
AMAG-423 (Digoxin Immune Fab)
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
AMAG-423 (digoxin immune fab): AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
|
Placebo
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Placebo: Normal saline, 30 minute IV infusion, every 6 hours x 4 days
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
Baseline characteristics by cohort
| Measure |
AMAG-423 (Digoxin Immune Fab)
n=28 Participants
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
AMAG-423 (digoxin immune fab): AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
|
Placebo
n=30 Participants
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Placebo: Normal saline, 30 minute IV infusion, every 6 hours x 4 days
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=2 Participants
|
30 Participants
n=4 Participants
|
58 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 6.59 • n=2 Participants
|
28.7 years
STANDARD_DEVIATION 6.87 • n=4 Participants
|
28.9 years
STANDARD_DEVIATION 6.68 • n=6 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=2 Participants
|
30 Participants
n=4 Participants
|
58 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=2 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=2 Participants
|
25 Participants
n=4 Participants
|
48 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=2 Participants
|
10 Participants
n=4 Participants
|
23 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=2 Participants
|
18 Participants
n=4 Participants
|
32 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Fetal Gestational Age at Consent
<= 27 weeks 6/7 days
|
11 weeks
n=2 Participants
|
11 weeks
n=4 Participants
|
22 weeks
n=6 Participants
|
|
Fetal Gestational Age at Consent
> 27 weeks 6/7 days
|
17 weeks
n=2 Participants
|
19 weeks
n=4 Participants
|
36 weeks
n=6 Participants
|
PRIMARY outcome
Timeframe: 36 weeks corrected gestational ageProportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
Outcome measures
| Measure |
AMAG-423 (Digoxin Immune Fab)
n=28 Participants
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
AMAG-423 (digoxin immune fab): AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
|
Placebo
n=30 Participants
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Placebo: Normal saline, 30 minute IV infusion, every 6 hours x 4 days
|
|---|---|---|
|
Proportion of Infants Who Have Severe IVH, NEC, or Death by 36 Weeks Corrected Gestational Age
Number of Stillbirths and Infant Deaths
|
4 infants
|
3 infants
|
|
Proportion of Infants Who Have Severe IVH, NEC, or Death by 36 Weeks Corrected Gestational Age
Number of Infants with Intraventricular Hemorrhage Grade ≥3
|
3 infants
|
2 infants
|
|
Proportion of Infants Who Have Severe IVH, NEC, or Death by 36 Weeks Corrected Gestational Age
Number of Infants with Necrotizing Enterocolitis
|
2 infants
|
0 infants
|
SECONDARY outcome
Timeframe: From treatment initiation to 24 hours post first doseMaternal change from baseline in serum creatinine to 24 hours post first dose
Outcome measures
| Measure |
AMAG-423 (Digoxin Immune Fab)
n=23 Participants
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
AMAG-423 (digoxin immune fab): AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
|
Placebo
n=30 Participants
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Placebo: Normal saline, 30 minute IV infusion, every 6 hours x 4 days
|
|---|---|---|
|
Change From Baseline in Serum Creatinine
|
1.0 μmol/L
Standard Deviation 8.51
|
-2.8 μmol/L
Standard Deviation 9.45
|
SECONDARY outcome
Timeframe: From treatment initiation until completion of treatment phase (up to 4 days)Maternal incidence of pulmonary edema during the treatment period
Outcome measures
| Measure |
AMAG-423 (Digoxin Immune Fab)
n=28 Participants
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
AMAG-423 (digoxin immune fab): AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
|
Placebo
n=30 Participants
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Placebo: Normal saline, 30 minute IV infusion, every 6 hours x 4 days
|
|---|---|---|
|
Incidence of Pulmonary Edema
|
0 Events
|
2 Events
|
Adverse Events
AMAG-423 (Digoxin Immune Fab)
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMAG-423 (Digoxin Immune Fab)
n=28 participants at risk
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
AMAG-423 (digoxin immune fab): AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
|
Placebo
n=29 participants at risk
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
Placebo: Normal saline, 30 minute IV infusion, every 6 hours x 4 days
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Psychiatric disorders
Claustrophobia
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Psychiatric disorders
Insomnia
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Reproductive system and breast disorders
Oedema genital
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.1%
2/28 • Number of events 2 • 36 weeks
|
3.4%
1/29 • Number of events 1 • 36 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
2/28 • Number of events 2 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • 36 weeks
|
3.4%
1/29 • Number of events 1 • 36 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
3.4%
1/29 • Number of events 1 • 36 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
6.9%
2/29 • Number of events 2 • 36 weeks
|
|
General disorders
Fatigue
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Infections and infestations
Otitis Media
|
0.00%
0/28 • 36 weeks
|
3.4%
1/29 • Number of events 1 • 36 weeks
|
|
Infections and infestations
Respiratory Tract Infection
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/28 • 36 weeks
|
3.4%
1/29 • Number of events 1 • 36 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
3.4%
1/29 • Number of events 1 • 36 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Metabolism and nutrition disorders
Nervous System Disorders
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Metabolism and nutrition disorders
Headache
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
3.6%
1/28 • Number of events 1 • 36 weeks
|
0.00%
0/29 • 36 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • 36 weeks
|
3.4%
1/29 • Number of events 1 • 36 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place