drugset / Trial / NCT04862221
TReatment for ImmUne Mediated PathopHysiology
Phase 2
Recruiting
163 enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ann & Robert H Lurie Children's Hospital of Chicago · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three arm, randomized, controlled trial of immunosuppressive therapy for children with acute liver failure. The study will determine if suppressing inflammatory responses with either corticosteroids or equine anti-thymocyte globulin therapy improves survival for children with this rare, life-threatening condition.
Timeline
- Start
- 2022-02-09
- Primary completion
- 2026-08
- Completion
- 2027-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 40 mg/kg | Intravenous |
| Subject | Methylprednisolone | Other / unclassified | 1 mg/kg | Intravenous |
| Subject | Methylprednisolone | Other / unclassified | 10 mg/kg | Intravenous |
| Subject | Prednisolone | Other / unclassified | 1 mg/kg | Oral |
| Background | Diphenhydramine | Unknown | 1 mg/kg | Intravenous |