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NCT04862221 · ClinicalTrials.gov registry record · Phase 2
TReatment for ImmUne Mediated PathopHysiology
A Phase 2 study of Hepatic Encephalopathy and Immune Dysregulation, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 163
- Enrollment target
- 20
- Study locations
NCT04862221: Recruiting Phase 2 study of Hepatic Encephalopathy and Immune Dysregulation, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT04862221 is a Phase 2 study of Hepatic Encephalopathy and Immune Dysregulation that is actively recruiting participants, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 163 participants, roughly in line with the 163-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04862221, a Phase 2 study of Hepatic Encephalopathy and Immune Dysregulation, is actively recruiting participants, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 163 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Alive and without a liver transplant 21 days following randomization
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2022-02-09 |
| Est. Completion | 2027-02 |
| Phase | Phase 2 |
What NCT04862221 shows while recruiting
NCT04862221 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 163-participant average among 12 other Hepatic Encephalopathy trials with a reported enrollment target.
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.
NCT04862221 names 20 study sites across 13 states, led by California, Missouri, New York.
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.
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).
Who is sponsoring clinical trial NCT04862221?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04862221's enrollment target sits among peer trials
163 6th of 12 higher than 7 of 12 other Hepatic Encephalopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Encephalopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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