Emapalumab for Severe Hepatitis
(SHIELD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this study is to see whether a medicine called emapalumab, a monoclonal antibody, is safe and works well for patients aged 1 year and older who have indeterminate severe hepatitis with T-cell activation and have not responded well to steroids or still need them.
This study has a Screening Cohort and an Intervention Cohort.
The Screening Cohort will enroll patients with severe hepatitis of all etiologies to observe and collect research samples. Patients enrolled on the Screening Cohort will be asked to participate on the Intervention Cohort if they develop steroid-refractory/ dependent indeterminate severe hepatitis (iSH-T). Additionally, patients may bypass the Screening Cohort and enroll directly in the Intervention Cohort if they already meet its eligibility criteria. Patients in the Intervention Cohort will be treated with emapalumab.
Are You a Good Fit for This Trial?
This trial is for people aged 1 year and older with severe hepatitis that hasn't improved with steroids or who still need steroids. It focuses on those whose hepatitis shows signs of T-cell activation, regardless of the cause.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Emapalumab
Trial Overview
The study is testing emapalumab, a monoclonal antibody medicine, to see if it is safe and effective for treating severe hepatitis in patients not responding well to steroid treatment. Patients may be observed first or start treatment right away if they qualify.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants on the Intervention Cohort will receive a combination of immunomodulatory regimen using emapalumab and methylprednisolone (or prednisone equivalent), aimed at controlling severe immune-mediated hepatitis and preventing progression to liver failure. Participants will be monitored closely for clinical improvement, laboratory normalization, and adverse events throughout the 56-day treatment period, with continued follow-up through Day 180 to assess long-term outcomes, including relapse, liver failure, survival, and safety.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Healthcare of Atlanta
Lead Sponsor
Sobi, Inc.
Industry Sponsor
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