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Recruiting Phase 2 Interventional

TReatment for ImmUne Mediated PathopHysiology

ClinicalTrials.gov ID: NCT04862221

Public ClinicalTrials.gov record NCT04862221. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Apr 22, 2026, 8:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2b, Double-Blind, Three Arm, Randomized, Placebo Controlled Trial With Restricted Response Adaptive Randomization Testing the Efficacy and Safety of High Dose Methylprednisolone or Equine Anti-Thymocyte Globulin as Treatment for Acute Liver Failure in Pediatric Patients

Study identification

NCT ID
NCT04862221
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Enrollment
163 participants

Conditions and interventions

Interventions

  • Diphenhydramine Drug
  • Equine anti-thymocyte globulin Drug
  • High-dose methylprednisolone Drug
  • Methylprednisolone Drug
  • Placebo for infusions Drug
  • Placebo for prednisolone Drug
  • Prednisolone Drug

Drug

Eligibility (public fields only)

Age range
1 Year to 18 Years
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 8, 2022
Primary completion
Jul 31, 2026
Completion
Jan 31, 2027
Last update posted
Mar 9, 2026

2022 – 2027

United States locations

U.S. sites
24
U.S. states
16
U.S. cities
23
Facility City State ZIP Site status
Children's Hospital Los Angeles Los Angeles California 90027 Recruiting
Lucile Packard Children's Hospital Palo Alto California 94304 Recruiting
Rady Children's Hospital San Diego California 92123 Recruiting
University of California San Francisco Benioff Children's Hospital San Francisco California 94158 Withdrawn
Children's Hospital Colorado Aurora Colorado 80045 Recruiting
Yale New Haven Children's Hospital New Haven Connecticut 06510 Withdrawn
Children's Healthcare of Atlanta - Arthur M. Blank Hospital Atlanta Georgia 30322 Withdrawn
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 Recruiting
Riley Hospital for Children Indianapolis Indiana 46202 Recruiting
Children's Hospital Boston Boston Massachusetts 02115 Recruiting
The Children's Mercy Hospital Kansas City Missouri 64108 Recruiting
St. Louis Children's Hospital St Louis Missouri 63110 Recruiting
The Mount Sinai Medical Center New York New York 10029 Withdrawn
NYP Morgan Stanley Children's Hospital New York New York 10032 Recruiting
Duke University Medical Center - Duke Children's Durham North Carolina 27710 Withdrawn
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 Recruiting
Cleveland Clinic Children's Cleveland Ohio 44195 Recruiting
The Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 Recruiting
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224 Recruiting
Children's Hospital Vanderbilt Nashville Tennessee 37232 Recruiting
UT Southwestern Medical Center Children's Health Dallas Texas 75235 Recruiting
Texas Children's Hospital Houston Texas 77030 Recruiting
Primary Children's Medical Center Salt Lake City Utah 84112 Withdrawn
Seattle Children's Hospital Seattle Washington 98105 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04862221, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 9, 2026 · Synced Apr 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04862221 live on ClinicalTrials.gov.

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