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Following a recommendation from the Data and Safety Monitoring Board (DSMB), the study was stopped early for futility. There were no safety concerns raised.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMAG-423 (digoxin immune fab) | Active Comparator | AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days |
|
| Placebo | Placebo Comparator | Normal saline, 30 minute IV infusion, every 6 hours x 4 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMAG-423 (digoxin immune fab) | Biological | AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Infants Who Have Severe IVH, NEC, or Death by 36 Weeks Corrected Gestational Age | Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age | 36 weeks corrected gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Creatinine | Maternal change from baseline in serum creatinine to 24 hours post first dose | From treatment initiation to 24 hours post first dose |
| Incidence of Pulmonary Edema |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36604 | United States | ||
| University of Kansas Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2018 |
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| Placebo | Other | Normal saline, 30 minute IV infusion, every 6 hours x 4 days |
|
Maternal incidence of pulmonary edema during the treatment period
| From treatment initiation until completion of treatment phase (up to 4 days) |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| Children's Hospital Foundation Building | Louisville | Kentucky | 40202 | United States |
| Louisiana State University Health Sciences Center in New Orleans | New Orleans | Louisiana | 70112 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Detroit Medical Center (DMC) | Detroit | Michigan | 48201 | United States |
| University Of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Case Medical Center-Case Western Reserve University (CWRU) | Cleveland | Ohio | 44106 | United States |
| Regional Obstetrical Consultants | Chattanooga | Tennessee | 37403 | United States |
| The University of Texas Medical Branch (UTMB) | Galveston | Texas | 77555 | United States |
| Texas Children's Hospital/Baylor College of Medicine | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center at Houston (UTHSC-H) | Houston | Texas | 77303 | United States |
| Baylor Scott & White Health | Temple | Texas | 76508 | United States |
| University of Virginia School Of Medicine | Charlottesville | Virginia | 29208 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Adalbertus Hospital | Gdansk | Pomeranian Voivodeship | 80-462 | Poland |
| Sefako Makgatho Health Sciences University | Pretoria | Gauteng | 0204 | South Africa |
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 |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Fetal Gestational Age at Consent | Number | weeks |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Infants Who Have Severe IVH, NEC, or Death by 36 Weeks Corrected Gestational Age | Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age | Posted | Number | infants | 36 weeks corrected gestational age |
|
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Creatinine | Maternal change from baseline in serum creatinine to 24 hours post first dose | Posted | Mean | Standard Deviation | μmol/L | From treatment initiation to 24 hours post first dose |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Pulmonary Edema | Maternal incidence of pulmonary edema during the treatment period | Posted | Number | Events | From treatment initiation until completion of treatment phase (up to 4 days) |
|
|
36 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 28 | 15 | 28 | 0 | 28 |
| EG001 | 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 | 0 | 29 | 8 | 29 | 0 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Otitis Media | Infections and infestations | Systematic Assessment |
| ||
| Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Nervous System Disorders | Metabolism and nutrition disorders | Systematic Assessment |
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| Headache | Metabolism and nutrition disorders | Systematic Assessment |
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| Foetal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Claustrophobia | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Oedema genital | Reproductive system and breast disorders | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Interest | Covis Pharma | 1-877-374-4177 | CTInterest@covispharma.com |
| Apr 29, 2026 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C050199 | digoxin antibodies Fab fragments |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| > 27 weeks 6/7 days |
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| Number of Infants with Necrotizing Enterocolitis |
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