Severe Hepatitis Intervention With Emapalumab for Liver Disease
ConditionHepatitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-30
SponsorChildren's Healthcare of Atlanta
About 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.
Eligibility criteria
Qualifiers
Age: Participants must be ≥ 1 year of age at the time of screening.
Evidence of Severe Hepatic Injury of all etiology (not just iSH/ iSH-T): Serum alanine aminotransferase (ALT) ≥ 1000 U/L documented within 7 days prior to enrollment.
Disqualifiers
Any condition impairing informed consent/assent or protocol compliance
Steroid-refractory, steroid-dependent, or relapse of hepatitis after stopping steroids and have an Indeterminate etiology of hepatitis based on standard of care, age appropriate evaluation
Age: ≥ 1 year
ALT ≥ 1000 U/L prior to initiation of any immune modulatory therapy
Trial design
Treatments tested in this trial
- Emapalumab
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Children's Healthcare of Atlanta
Lead sponsor
Sobi, Inc.
Collaborator
Source ClinicalTrials.gov