TReatment for ImmUne Mediated PathopHysiology

PHASE2RecruitingINTERVENTIONAL
Enrollment

163

Participants

Timeline

Start Date

February 9, 2022

Primary Completion Date

April 1, 2027

Study Completion Date

May 31, 2027

Conditions
Acute Liver FailureFulminant Hepatic FailureHepatic EncephalopathyAcute Liver InjuryImmune Dysregulation
Interventions
DRUG

High-dose methylprednisolone

Subjects in the high-dose methylprednisolone arm will receive an initial dose of methylprednisolone IV 10 mg/kg/day for 3 days and 5 mg/kg/day on Day 4. Normal saline will be used as placebo pre-medications and infusions given at the same volume and duration as the eATG infusions.

DRUG

Equine anti-thymocyte globulin

Subjects will receive eATG IV 40 mg/kg/day on Days 1- 4. Day 1 eATG infusion is run over 8 hours and Day 2-4 infusions are run over 4 hours.

DRUG

Prednisolone

"Subjects will receive prednisolone 1 mg/kg on Days 5-13 followed by a gradual taper with discontinuation at 42 Days as indicated below.~Days 5 - 13 Prednisolone PO 1 mg/kg/day (max 50 mg/day)~Days 14- 20 Prednisolone PO 0.5 mg/kg/day (max 25 mg/day)~Days 21 - 27 Prednisolone PO 0.3 mg/kg/day (max 15 mg/day)~Days 28 - 34 Prednisolone PO 0.1 mg/kg/day (max 5 mg/day)~Days 35 - 41 Prednisolone PO 0.1 mg/kg every OTHER day (max 5 mg every other day)~Day 42 Discontinue"

DRUG

Placebo for prednisolone

"Subjects will receive 1 mg/kg/day of oral placebo for prednisolone on days 5-13 followed by a gradual taper to discontinuation at 42 days as indicated below. Subjects receiving oral placebo will be given a solution that closely resembles the treatment drug.~Days 5 - 13 Placebo for Prednisolone PO 1 mg/kg/day (max 50 mg/day)~Days 14- 20 Placebo for Prednisolone PO 0.5 mg/kg/day (max 25 mg/day)~Days 21 - 27 Placebo for Prednisolone PO 0.3 mg/kg/day (max 15 mg/day)~Days 28 - 34 Placebo for Prednisolone PO 0.1 mg/kg/day (max 5 mg/day)~Days 35 - 41 Placebo for Prednisolone PO 0.1 mg/kg every OTHER day (max 5 mg every other day)~Day 42 Discontinue"

DRUG

Placebo for infusions

Subjects randomized to the supportive care alone arm will receive normal saline in place of all study treatments (skin test, premedication and IV infusions) on Days 1-4 given at the same volume and duration as the eATG infusions.

DRUG

Diphenhydramine

Subjects in the eATG arm will receive pre-treatment medication diphenhydramine IV 1 mg/kg prior to start of eATG infusion.

DRUG

Methylprednisolone

Subjects in the eATG arm will receive pre-treatment medication methylprednisolone IV 1 mg/kg prior to start of eATG infusion.

Trial Locations (23)

10029

WITHDRAWN

The Mount Sinai Medical Center, New York

10032

RECRUITING

NYP Morgan Stanley Children's Hospital, New York

15224

RECRUITING

Children's Hospital of Pittsburgh, Pittsburgh

19104

RECRUITING

The Children's Hospital of Philadelphia, Philadelphia

27710

WITHDRAWN

Duke University Medical Center - Duke Children's, Durham

30322

RECRUITING

Children's Healthcare of Atlanta - Arthur M. Blank Hospital, Atlanta

44195

RECRUITING

Cleveland Clinic Children's, Cleveland

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

RECRUITING

Riley Hospital for Children, Indianapolis

60611

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

63110

RECRUITING

St. Louis Children's Hospital, St Louis

64108

RECRUITING

The Children's Mercy Hospital, Kansas City

75235

RECRUITING

UT Southwestern Medical Center Children's Health, Dallas

77030

RECRUITING

Texas Children's Hospital, Houston

80045

RECRUITING

Children's Hospital Colorado, Aurora

84112

WITHDRAWN

Primary Children's Medical Center, Salt Lake City

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

92123

RECRUITING

Rady Children's Hospital, San Diego

94158

WITHDRAWN

University of California San Francisco Benioff Children's Hospital, San Francisco

94304

RECRUITING

Lucile Packard Children's Hospital, Palo Alto

98105

RECRUITING

Seattle Children's Hospital, Seattle

06510

WITHDRAWN

Yale New Haven Children's Hospital, New Haven

02115

RECRUITING

Children's Hospital Boston, Boston

All Listed Sponsors
collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH