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Can calming the immune system save Kids' livers?

NCT ID NCT04862221

Disease control Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Updated 4 times

Summary

This study tests whether two drugs that calm the immune system—high-dose steroids or anti-thymocyte globulin—can help children with sudden, severe liver failure survive without needing a liver transplant. About 163 children aged 1 to 17 will be randomly assigned to receive one of these drugs or a placebo. The main goal is to see if more children are alive with their own liver 21 days after treatment.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

44 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

1 year to 18 years

Sex

Anyone

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: 1. Patient with liver injury of ≤ 6 weeks duration resulting in an international normalization ratio (INR) of ≥ 1.5 or \< 2.0 (not corrected by vitamin K) with evidence of hepatic encephalopathy (HE), INR of ≥ 1.5 or \< 2.0 for at least 7 days duration without evidence of HE or INR ≥ 2.0 without evidence of HE. 2. Age is greater than or equal to 1 year and less than 18 years of age. 3. Patient or their legally authorized representative(s) (LAR) must consent (and assent, if applicable) to be in the study and must have signed and dated an approved informed consent form which conforms to federal and institutional guidelines. 4. Females of reproductive potential should not plan on conceiving children during the study and must agree to use a medically accepted form of contraception. Exclusion Criteria: 1. Evidence of active infection with Hepatitis A, B, C, E or evidence of acute herpes simplex virus (HSV) or adenovirus infection 2. Travel within the past 3 months to an area highly endemic for Hepatitis E 3. Diagnosis of hemophagocytic lymphohistiocytosis (HLH) Note: Patients with a history of consanguinity and/or central nervous system (CNS) dysfunction that is exaggerated compared to the degree of liver dysfunction (as judged by the site investigator) will not be enrolled until results of rapid genetic testing are available. Turn-around time for genetic testing results is estimated to be 72-96 hours. 4. Aplastic anemia as defined by standardized criteria \[1\] diagnosed prior to enrollment 5. Diagnosis of autoimmune Hepatitis (AIH) 6. Diagnosis of acute Wilson disease 7. Diagnosis of inborn error of metabolism Note: Suspicion of metabolic disease is not an exclusion for entry into the Trial. 8. Diagnosis of acute drug or toxin-induced liver injury 9. History of recreational drug use within the past 4 weeks 10. Therapy with an immunosuppressive agent, including chemotherapy, biological therapies or an experimental drug or device within the past 6 weeks 11. Liver injury due to ischemia 12. Liver dysfunction diagnosed more than 6 weeks prior to screening 13. History of allergy to horse dander 14. Sepsis 15. Imminent risk of death as judged by the clinical site investigator, including but not limited to; signs of cerebral herniation at the time of enrollment and presence of intractable arterial hypotension 16. Solid organ or stem cell transplant recipient 17. Pregnant or breast-feeding at the time of proposed study entry 18. Clinical AIDS or HIV positive 19. History of any form of malignant neoplasm and/or tumors treated within five years prior to study entry (other than non-melanoma skin cancer or in situ cervical cancer) or where there is current evidence of recurrent or metastatic disease 20. Received a live-virus vaccine within 4 weeks of study entry 21. Patients with positive respiratory secretion testing for respiratory viral infection including SARS-CoV-2, influenza and respiratory syncytial virus only if they also have declining respiratory function 22. Psychiatric or addictive disorders that would preclude obtaining informed consent/assent 23. Patient is unwilling or unable to adhere with study requirements and procedures 24. Currently receiving other experimental therapies

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Conditions

The condition(s) this trial relates to.

acute liver failure hepatic encephalopathy Hepatic Insufficiency immune system disorder liver disorder liver failure

As listed by the trial registrant

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

Acute liver failure Acute liver injury Fulminant hepatic failure Hepatic encephalopathy Immune dysregulation

Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Children's Hospital Boston

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital Vanderbilt

    Nashville, Tennessee, 37232, United States

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Lucile Packard Children's Hospital

    Palo Alto, California, 94304, United States

  • NYP Morgan Stanley Children's Hospital

    New York, New York, 10032, United States

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • The Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • UT Southwestern Medical Center Children's Health

    Dallas, Texas, 75235, United States

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