Clinical Trial NCT04862221
Pediatric Acute Liver Failure Immune Response Network (PALF IRN) TReatment for ImmUne Mediated PathopHysiology A Phase 2b, Double-Blind, Three Arm, Randomized, Placebo Controlled Trial with Restricted Response Adaptive Randomization Testing the Efficacy and Safety of High Dose Methylprednisolone or Equine Anti-Thymocyte Globulin as Treatment for Acute Liver Failure in Pediatric Patients
- ClinicalTrials.gov ID: NCT04862221
- Not accepting healthy volunteers
- UTSW Principal Investigator: NORBERTO RODRIGUEZ-BAEZ
summary
This is a phase 2b, double-blind, three arm, randomized, placebo controlled trial with restricted response adaptive randomization (RAR). The trial is designed to test the efficacy and safety of high dose methylprednisolone or equine anti-thymocyte globulin (eATG) as compared to supportive care alone for the treatment of acute liver failure in pediatric patients. The primary outcome will be survival with native liver at 21 days following study entry.
objective
Determine the more effective therapy, high-dose methylprednisolone or equine anti-thymocyte globulin, and compare the efficacy of the chosen agent versus supportive care alone to improve spontaneous survival with native liver at 21 days