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RECRUITING Phase 2

TReatment for ImmUne Mediated PathopHysiology

NCT04862221 · View on ClinicalTrials.gov ↗

Study Summary

TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three arm, randomized, controlled trial of immunosuppressive therapy for children with acute liver failure. The study will determine if suppressing inflammatory responses with either corticosteroids or equine anti-thymocyte globulin therapy improves survival for children with this rare, life-threatening condition.

Interventions

  • DRUG Prednisolone
  • DRUG High-dose methylprednisolone
  • DRUG Equine anti-thymocyte globulin
  • DRUG Placebo for prednisolone
  • DRUG Placebo for infusions

Study Locations (20)

California

  • Children's Hospital Los Angeles — Los Angeles
  • Lucile Packard Children's Hospital — Palo Alto
  • Rady Children's Hospital — San Diego
  • University of California San Francisco Benioff Children's Hospital — San Francisco

Missouri

  • The Children's Mercy Hospital — Kansas City
  • St. Louis Children's Hospital — St Louis

New York

  • The Mount Sinai Medical Center — New York
  • NYP Morgan Stanley Children's Hospital — New York

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati
  • Cleveland Clinic Children's — Cleveland

Pennsylvania

  • The Children's Hospital of Philadelphia — Philadelphia
  • Children's Hospital of Pittsburgh — Pittsburgh

Colorado

  • Children's Hospital Colorado — Aurora

Connecticut

  • Yale New Haven Children's Hospital — New Haven

Georgia

  • Children's Healthcare of Atlanta - Arthur M. Blank Hospital — Atlanta

Trial Details

FieldValue
Enrollment Target 163 participants
Start Date 2022-02-09
Est. Completion 2027-02
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04862221

The ClinicalTrials.gov registry entry for NCT04862221 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 163 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Hepatic Encephalopathy appearing as the primary indexed condition, and to 5 interventions — of which Prednisolone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04862221 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Missouri, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04862221 about?

NCT04862221 is a clinical study titled "TReatment for ImmUne Mediated PathopHysiology". TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three arm, randomized, controlled trial of immunosuppressive therapy for children with acute liver failure. The study will determine if suppressing inflammatory responses with either corticosteroids or equine anti-thymocyte g...

What is the current status of trial NCT04862221?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2022-02-09. Estimated completion is 2027-02.

What conditions does trial NCT04862221 study?

This clinical trial studies the following conditions: Hepatic Encephalopathy, Immune Dysregulation, Acute Liver Failure, Fulminant Hepatic Failure, Acute Liver Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04862221?

The interventions under investigation include: Prednisolone (DRUG), High-dose methylprednisolone (DRUG), Equine anti-thymocyte globulin (DRUG), Placebo for prednisolone (DRUG), Placebo for infusions (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04862221?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04862221 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial