Severe PreeclampsiaPhase 2/3NCT03008616
Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
A Phase 2/3 study testing AMAG-423 (digoxin immune fab) in people with Severe Preeclampsia, run by AMAG Pharmaceuticals, Inc. at 18 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Severe Preeclampsia
- What is being tested?
- AMAG-423 (digoxin immune fab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 12 Apr 2017to 13 Aug 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States16 sites
University of Maryland
Baltimore, Maryland, 21201
University of Virginia School Of Medicine
Charlottesville, Virginia, 29208
Regional Obstetrical Consultants
Chattanooga, Tennessee, 37403
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
University Hospitals Case Medical Center-Case Western Reserve University (CWRU)
Cleveland, Ohio, 44106
Detroit Medical Center (DMC)
Detroit, Michigan, 48201
The University of Texas Medical Branch (UTMB)
Galveston, Texas, 77555
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030
The University of Texas Health Science Center at Houston (UTHSC-H)
Houston, Texas, 77303
University Of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Kansas Medical Center
Kansas City, Kansas, 66160
Children's Hospital Foundation Building
Louisville, Kentucky, 40202
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of South Alabama
Mobile, Alabama, 36604
Louisiana State University Health Sciences Center in New Orleans
New Orleans, Louisiana, 70112
Baylor Scott & White Health
Temple, Texas, 76508
South Africa1 site
Sefako Makgatho Health Sciences University
Pretoria, Gauteng, 0204
About this study
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
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
- Severe Preeclampsia
- Being tested
- AMAG-423 (digoxin immune fab), Placebo
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMAG-423 (digoxin immune fab)Biological
Also called DigiFab
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
PlaceboOther
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: AMAG-423 (digoxin immune fab) |
| Placebo | Placebo comparator | Normal saline, 30 minute IV infusion, every 6 hours x 4 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 weeks corrected gestational age
Secondary outcomes (2)
Change From Baseline in Serum Creatinine
Maternal change from baseline in serum creatinine to 24 hours post first dose
Measured: From treatment initiation to 24 hours post first dose
Incidence of Pulmonary Edema
Maternal incidence of pulmonary edema during the treatment period
Measured: From treatment initiation until completion of treatment phase (up to 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start12 Apr 2017
- Primary completion13 Aug 2020
- Study completion13 Aug 2020
Why it stopped: Following a recommendation from the Data and Safety Monitoring Board (DSMB), the study was stopped early for futility. There were no safety concerns raised.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008616
- Sponsor's protocol ID
- AMAG-423-201
- Status last verified
- Aug 2024
- First submitted
- 20 Dec 2016
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03008616
- Acronym / sponsor ID
- AMAG-423-201
- Conditions
- Severe Preeclampsia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following a recommendation from the Data and Safety Monitoring Board (DSMB), the study was stopped early for futility. There were no safety concerns raised.
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMAG-423 (digoxin immune fab) | Active comparator | 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 |
| Placebo | Placebo comparator | Other: PlaceboNormal saline, 30 minute IV infusion, every 6 hours x 4 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Decision to deliver within 24 hours has been made
- Weight > 150 kg
- Eclampsia
- Significant antecedent obstetrical problems
- Clinically significant fetal anomaly or chromosomal abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMAG-423 (digoxin immune fab)Also: DigiFabAMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days | Biological | AMAG-423 (digoxin immune fab) |
| PlaceboNormal saline, 30 minute IV infusion, every 6 hours x 4 days | Other | Placebo |
Primary outcome
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
2 secondary outcomes
Change From Baseline in Serum Creatinine
Time frame: From treatment initiation to 24 hours post first dose
Incidence of Pulmonary Edema
Time frame: From treatment initiation until completion of treatment phase (up to 4 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AMAG-423 (digoxin immune fab) in people with Severe Preeclampsia, run by AMAG Pharmaceuticals, Inc. at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Poland, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Infants Who Have Severe IVH, NEC, or Death by 36 Weeks Corrected Gestational Age (time frame: 36 weeks corrected gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.