HepatitisPhase 2SHIELDNCT07744919
Severe Hepatitis Intervention With Emapalumab for Liver Disease
A Phase 2 study testing Emapalumab in people with Hepatitis, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Hepatitis
- What is being tested?
- Emapalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Sep 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Any condition impairing informed consent/assent or protocol compliance
- Inclusion Criteria (Intervention Cohort; patients who meet Intervention Cohort eligibility can bypass Screening Cohort enrollment):
- 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
- Evidence of T-cell activation at initial diagnosis, as indicated by one of the following:
Show all 33Show fewer
- sIL2R > 2× upper limit of normal (ULN)
- CXCL9 > 5× ULN
- CD8+ T-cell infiltration in the liver
- INR < 2.0 without evidence of hepatic encephalopathy
- Exclusion Criteria (Intervention Cohort; patients who meet Intervention Cohort eligibility can bypass Screening Cohort enrollment):
- Patients with known Liver failure (defined as INR >2 on two consecutive occasions without hepatic encephalopathy (HE), or INR ≥1.5 with evidence of HE)
- Evidence of chronic liver disease or parenchymal nodularity as demonstrated on imaging (US, CT, or MRI)
- Evidence of hepatic encephalopathy
- Severe acquired aplastic anemia at presentation
- Organ dysfunction assessment defined below:
- Renal dysfunction: eGFR < 30 mL/min/1.73m² or
- Mechanical Ventilation
- Persistent systemic infection despite appropriate antimicrobial therapy
- Active infection with Hepatitis A, B, C, HIV, or herpes simplex virus
- Active mycobacteria (typical and atypical), Histoplasma Capsulatum, Herpes zoster infections.
- Patients with positive respiratory viral infection, including adenovirus, rhinovirus/enterovirus, SARS-CoV-2, influenza, and respiratory syncytial virus, only if they also have declining respiratory function needing positive pressure support. Suspected primary hemophagocytic lymphohistiocytosis based on patients with a history of consanguinity and/or central nervous system dysfunction or other clinical manifestations that is exaggerated compared to the degree of liver dysfunction (as judged by the site investigator and study team)
- Diagnosis of Autoimmune Hepatitis, Wilson Disease, inborn error of metabolism, acute drug or toxin-induced liver injury, or ischemic liver injury
- History of severe hypersensitivity or allergy to any component of this study regimen
- History of confirmed malignancy
- History of recreational drug use within the past 4 weeks, excluding cannabinoids
- Therapy with an immunosuppressive agent or an experimental drug within the past 6 weeks
- Pregnant, planning to become pregnant during study window, or breastfeeding at time of study entry
- Patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method (e.g. hormonal contraceptives, intrauterine device, or double-barrier method) for the duration of their study participation. Patients must maintain adequate contraception for at least 4 weeks after their last dose of emapalumab.
- Live-virus vaccination within 4 weeks of study entry or anticipated need for a live or live attenuated vaccine within 4 weeks after the last dose of emapalumab
- Peceived Bacillus Calmette-Guerin vaccine within 12 weeks prior to screening
- Patient or parent/guardian unable to give informed consent or unable to comply with the treatment protocol
- Prisoners will be excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Arthur M. Blank Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Shanmuganathan Chandrakasan, MD, 404-727-8877, Shanmuganathan.Chandrakasan@emory.edu
Kate Silvis, Katherine.Silvis@choa.org
About this study
Official title: A Phase 2 Study of Emapalumab for Prevention of Liver Failure in Pediatric Indeterminate Severe Hepatitis Associated With T-Cell Activation: Severe Hepatitis Intervention With Emapalumab for Liver Disease
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.
Read the detailed description
This clinical protocol evaluates the use of emapalumab, an anti-IFN-γ monoclonal antibody, in children aged ≥1 year with steroid-refractory or steroid-dependent indeterminate severe hepatitis with T cell activation (iSH-T). This study aims to establish a safe and effective treatment pathway for a previously steroid-refractory/dependent subjects with iSH-T.
Pediatric severe acute hepatitis is a rare but serious disorder that can rapidly progress to liver failure. Previously healthy children who develop severe acute hepatitis can unpredictably progress to pediatric acute liver failure (PALF) over the course of days to weeks. Importantly, as many as 30-50% of all PALF cases have no specific causal etiology for their liver failure and are termed indeterminate PALF (iPALF) and are at the highest risk for liver transplantation. Work from the PALF study group investigators has identified that iPALF is a leading indication for liver transplantation in children. Additional investigation indicates that iPALF patients have significant T cell activation and CD8+ T cell infiltration of their hepatic tissue. There are reports using immunosuppression in iPALF and PALF with favorable results and it is also the subject of a current multicenter trial in children (NCT04862221).
- Conditions
- Hepatitis
- Being tested
- Emapalumab
- Keywords
- Hepatitis, Emapalumab, iSH-T, anti-IFN-gamma monoclonal antibody, Severe Hepatitis Associated with T-Cell Activation, Severe Hepatitis, Steroid-refractory hepatitis, steroid-dependent hepatitis, relapse hepatitis, Severe Hepatic Injury
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmapalumabDrug
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 group | Role | What they receive |
|---|---|---|
| Intervention Cohort | Experimental | 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. Receives: Drug: Emapalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Liver Failure
INR >2 on two consecutive occasions without hepatic encephalopathy (HE), or INR ≥1.5 with evidence of HE
Measured: 30, 90, and 180 days after the start of emapalumab
Secondary outcomes (18)
Complete Response (CR)
A complete response (CR) is defined by normalization or near-normalization of liver injury markers and hepatic function. Patients achieving CR will demonstrate an ALT < 2.5X ULN together with an INR ≤ 1.2.
Measured: throughout study participation/ up to 180 days
Cytokine and Chemokine Profiling
The cytokine milieu including interferon-γ, interferon-stimulated gene products, TNF-α, IL-6, IL-18, CXCL9, and others will be quantified to define the inflammatory environment at baseline and during treatment.
Measured: through study participation/ up to 180 days
Emapalumab Immunologic Effects
Change in circulating activated CD8+ T cells from the initiation of emapalumab to Days 7, 14, 30, 60, 90, and 180 of study
Measured: through study completion/ up to 180 days
Incidence and Severity of Adverse Events
Incidence of all adverse events of all grades as defined by CTCAE version 5.0
Measured: from first emapalumab dose through study completion, up to 180 days
Population Summary Measure
The population summary measure will be the Complete Response rate, which will be estimated as the number of participants with Complete Response divided by the total number of participants in the efficacy sample population.
Measured: throughout study participation/ up to 180 days
Time to First Complete Response
Time to first CR will be estimated using time-to-event methods. Death or liver transplant before CR will be treated as competing risks, and cumulative incidence functions will be used to estimate probabilities.
Measured: throughout study participation/ up to 180 days
Partial Response (PR)
This is defined as an ALT decrease 50% from initiation of emapalumab, but ALT >2.5X ULN with INR< 1.2.
Measured: throughout study participation/ up to 180 days
Sustained Response Off Therapy (SR)
ALT levels remaining < 2.5X ULN for at least two consecutive months after completion of emapalumab.
Measured: throughout study participation/ up to 180 days
Non-Response (NR)
Patients are considered non-responders if clinically relevant worsening with progression to liver failure.
Measured: After 4 doses of emapalumab/ about 2 weeks after start of therapy
Proportion of Patients with Overall Response (CR or PR)
The proportion of patients achieving overall response (OR, defined as CR or PR) will be reported at Week 8 with exact confidence intervals. Missing values will be treated as non-response
Measured: from first dose of emapalumab to week 8 of therapy
Time to First Overall Response (OR)
Time to first OR will be analyzed using cumulative incidence methods, with death or liver transplant treated as competing risks.
Measured: throughout study participation/ up to 180 days
Sustained CR Off Therapy at Day 180
The proportion of patients achieving a sustained CR off therapy (SROT) at Day 180 will be summarized with exact confidence intervals. Patients without Day 180 data or therapy information will be considered non-SROT.
Measured: 180 days on study therapy
Overall Survival with Native Liver
Survival with native liver will be estimated using Kaplan-Meier methods. Survival probabilities and 95% confidence intervals will be presented at each landmark time point.
Measured: days 30, 60, 90, and 180
Proportion of Patients Receiving Liver Transplantation:
Cumulative incidence of transplant will be calculated at Days 30, 90, and 180, with death as a competing risk.
Measured: days 30, 90, and 180
Change in Systemic Inflammatory Markers
Longitudinal changes in sIL2R, and CXCL9 will be evaluated using mixed-effects models for repeated measures.
Measured: throughout study participation/ up to 180 days
Change in Circulating Activated CD8+ T Cells
Changes in activated CD8+ T cells over time will be analyzed similarly with mixed-effects models, supplemented by graphical summaries.
Measured: throughout study participation/ up to 180 days
Corticosteroid Exposure and Time to Discontinuation
Cumulative corticosteroid exposure (prednisone equivalents) will be summarized descriptively. Time to discontinuation will be estimated using Kaplan-Meier methods, with competing-risk analyses considering death or transplant.
Measured: throughout study participation/ up to 180 days
Incidence of Hepatitis Relapses
Defined as ALT re-elevation with concurrent sIL2R and CXCL9 rise. Time-to-relapse will be summarized with cumulative incidence functions.
Measured: After initial improvement during weaning or cessation of therapy, up to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Collaborators
- Sobi, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744919
- Sponsor's protocol ID
- SHIELD
- Acronym
- SHIELD
- Status last verified
- Jul 2026
- First submitted
- 29 May 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be stored. This will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. The study data entry and study management systems used by clinical sites and research staff will be secured and password protected. Neither data nor specimens will be shared across participating sites. Deidentified data that supports the findings of this study will be made available by the Principal Investigator, upon reasonable request. At the end of the study, all records will continue to be kept in a secure location for as long a period as dictated by local IRB and Institutional regulations. All study databases will be de-identified and archived.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Emapalumab for Prevention of Liver Failure in Pediatric Indeterminate Severe Hepatitis Associated With T-Cell Activation: Severe Hepatitis Intervention With Emapalumab for Liver Disease
- ClinicalTrials.gov ID
- NCT07744919
- Acronym / sponsor ID
- SHIELD / SHIELD
- Conditions
- Hepatitis
- Keywords
- Hepatitis, Emapalumab, iSH-T, anti-IFN-gamma monoclonal antibody, Severe Hepatitis Associated with T-Cell Activation, Severe Hepatitis, Steroid-refractory hepatitis, steroid-dependent hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Collaborators
- Sobi, Inc.
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical protocol evaluates the use of emapalumab, an anti-IFN-γ monoclonal antibody, in children aged ≥1 year with steroid-refractory or steroid-dependent indeterminate severe hepatitis with T cell activation (iSH-T). This study aims to establish a safe and effective treatment pathway for a previously steroid-refractory/dependent subjects with iSH-T.
Pediatric severe acute hepatitis is a rare but serious disorder that can rapidly progress to liver failure. Previously healthy children who develop severe acute hepatitis can unpredictably progress to pediatric acute liver failure (PALF) over the course of days to weeks. Importantly, as many as 30-50% of all PALF cases have no specific causal etiology for their liver failure and are termed indeterminate PALF (iPALF) and are at the highest risk for liver transplantation. Work from the PALF study group investigators has identified that iPALF is a leading indication for liver transplantation in children. Additional investigation indicates that iPALF patients have significant T cell activation and CD8+ T cell infiltration of their hepatic tissue. There are reports using immunosuppression in iPALF and PALF with favorable results and it is also the subject of a current multicenter trial in children (NCT04862221).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Cohort | Experimental | Drug: EmapalumabParticipants 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. |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (33 listed)
- Any condition impairing informed consent/assent or protocol compliance
- Inclusion Criteria (Intervention Cohort; patients who meet Intervention Cohort eligibility can bypass Screening Cohort enrollment):
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmapalumabParticipants 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. | Drug | Intervention Cohort |
Primary outcome
Incidence of Liver Failure
Time frame: 30, 90, and 180 days after the start of emapalumab
INR >2 on two consecutive occasions without hepatic encephalopathy (HE), or INR ≥1.5 with evidence of HE
18 secondary outcomes
Complete Response (CR)
Time frame: throughout study participation/ up to 180 days
Cytokine and Chemokine Profiling
Time frame: through study participation/ up to 180 days
Emapalumab Immunologic Effects
Time frame: through study completion/ up to 180 days
Incidence and Severity of Adverse Events
Time frame: from first emapalumab dose through study completion, up to 180 days
Population Summary Measure
Time frame: throughout study participation/ up to 180 days
Time to First Complete Response
Time frame: throughout study participation/ up to 180 days
Partial Response (PR)
Time frame: throughout study participation/ up to 180 days
Sustained Response Off Therapy (SR)
Time frame: throughout study participation/ up to 180 days
Non-Response (NR)
Time frame: After 4 doses of emapalumab/ about 2 weeks after start of therapy
Proportion of Patients with Overall Response (CR or PR)
Time frame: from first dose of emapalumab to week 8 of therapy
Time to First Overall Response (OR)
Time frame: throughout study participation/ up to 180 days
Sustained CR Off Therapy at Day 180
Time frame: 180 days on study therapy
Overall Survival with Native Liver
Time frame: days 30, 60, 90, and 180
Proportion of Patients Receiving Liver Transplantation:
Time frame: days 30, 90, and 180
Change in Systemic Inflammatory Markers
Time frame: throughout study participation/ up to 180 days
Change in Circulating Activated CD8+ T Cells
Time frame: throughout study participation/ up to 180 days
Corticosteroid Exposure and Time to Discontinuation
Time frame: throughout study participation/ up to 180 days
Incidence of Hepatitis Relapses
Time frame: After initial improvement during weaning or cessation of therapy, up to Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be stored. This will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. The study data entry and study management systems used by clinical sites and research staff will be secured and password protected. Neither data nor specimens will be shared across participating sites. Deidentified data that supports the findings of this study will be made available by the Principal Investigator, upon reasonable request. At the end of the study, all records will continue to be kept in a secure location for as long a period as dictated by local IRB and Institutional regulations. All study databases will be de-identified and archived.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Emapalumab in people with Hepatitis, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanmuganathan Chandrakasan, MD (404-727-8877, Shanmuganathan.Chandrakasan@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Liver Failure (time frame: 30, 90, and 180 days after the start of emapalumab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.