Severe Hepatitis Intervention With Emapalumab for Liver Disease

Conditions

• Hepatitis

Eligibility Criteria

Sex

ALL

Age

1 Year - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Emapalumab — DRUG
  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.

Study Details

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.

Key Dates

First listed

Aug 4, 2026

Start date

Sep 1, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2031

Completion

Sep 30, 2032

Study Design

Enrollment

28 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Intervention Cohort
  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.

Primary Outcome Measure

Incidence of Liver Failure [ Time Frame: 30, 90, and 180 days after the start of emapalumab ]

Central Contacts

• Shanmuganathan Chandrakasan, MD
  404-727-8877
  [email protected]
• Maria Frazer
  4047856162
  [email protected]

Locations (1)

Find similar trials in Atlanta, GA

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