High-dose methylprednisolone for Hepatic Coma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hepatic Coma+7 More
High-dose methylprednisolone - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will help determine if suppressing the immune response with either corticosteroids or equine anti-thymocyte globulin therapy helps improve survival rates for children with acute liver failure.

Eligible Conditions
  • Hepatic Coma
  • Liver Failure, Acute
  • Immune Dysregulations
  • Liver

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 1 Secondary · Reporting Duration: 180 days

180 days
Survival with native liver (SNL)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

High-dose methylprednisolone
1 of 3
Equine anti-thymocyte globulin
1 of 3
Supportive care
1 of 3

Experimental Treatment

Non-Treatment Group

160 Total Participants · 3 Treatment Groups

Primary Treatment: High-dose methylprednisolone · Has Placebo Group · Phase 2

High-dose methylprednisoloneExperimental Group · 2 Interventions: Prednisolone, High-dose methylprednisolone · Intervention Types: Drug, Drug
Equine anti-thymocyte globulinExperimental Group · 4 Interventions: Equine anti-thymocyte globulin, Prednisolone, Methylprednisolone, Diphenhydramine · Intervention Types: Drug, Drug, Drug, Drug
Supportive carePlaceboComparator Group · 2 Interventions: Placebo for prednisolone, Placebo for infusions · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisolone
FDA approved
Methylprednisolone
FDA approved
Diphenhydramine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 180 days

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
230 Previous Clinical Trials
5,178,231 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,122 Previous Clinical Trials
4,062,596 Total Patients Enrolled
Ed Doo, MDStudy DirectorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
13 Previous Clinical Trials
7,721 Total Patients Enrolled
Averell Sherker, MDStudy DirectorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
16 Previous Clinical Trials
9,029 Total Patients Enrolled
Estella M Alonso, MDPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago
Valerie L Durkalski-Mauldin, PhDPrincipal InvestigatorMedical University of South Carolina

Eligibility Criteria

Age < 65 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have liver injury of ≤ 6 weeks duration resulting in an INR of ≥ 1.5 and < 2.0 (not corrected by vitamin K) with evidence of HE or INR ≥ 2.0 without evidence of HE.
You are female and you are not of reproductive potential
You are aged at least 1 year and less than 18 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.