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Promising preeclampsia drug trial halted early – what happened?

NCT ID NCT03008616

Disease control Sponsor: AMAG Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called AMAG-423 (Digoxin Immune Fab) in pregnant women with severe preeclampsia, a dangerous condition of high blood pressure during pregnancy. The goal was to see if the drug could reduce serious health problems in babies, such as bleeding in the brain or bowel issues, and improve kidney function in mothers. The trial was stopped early after enrolling 58 participants, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

58 people

The number who actually took part.

Started

Apr 2017

Finished

Aug 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

preeclampsia severe pre-eclampsia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe preeclampsia

Contacts and locations

Locations

  • Adalbertus Hospital

    Gdansk, Pomeranian Voivodeship, 80-462, Poland

  • Baylor Scott & White Health

    Temple, Texas, 76508, United States

  • Children's Hospital Foundation Building

    Louisville, Kentucky, 40202, United States

  • Detroit Medical Center (DMC)

    Detroit, Michigan, 48201, United States

  • Louisiana State University Health Sciences Center in New Orleans

    New Orleans, Louisiana, 70112, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Regional Obstetrical Consultants

    Chattanooga, Tennessee, 37403, United States

  • Sefako Makgatho Health Sciences University

    Pretoria, Gauteng, 0204, South Africa

  • 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

  • The University of Texas Medical Branch (UTMB)

    Galveston, Texas, 77555, United States

  • University Hospitals Case Medical Center-Case Western Reserve University (CWRU)

    Cleveland, Ohio, 44106, United States

  • University Of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of South Alabama

    Mobile, Alabama, 36604, United States

  • University of Virginia School Of Medicine

    Charlottesville, Virginia, 29208, United States

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