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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

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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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Jul 2024

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At a glance

  • Drugs Antithymocyte globulin (Primary) ; Methylprednisolone (Primary) ; Diphenhydramine; Prednisolone
  • Indications Liver failure
  • Focus Therapeutic Use
  • Acronyms TRIUMPH

    • Most Recent Events

    • 01 Apr 2024 Planned End Date changed from 31 Jan 2026 to 31 Jan 2027.
    • 01 Apr 2024 Planned primary completion date changed from 30 Apr 2025 to 31 Jan 2026.
    • 01 Jun 2023 Planned number of patients changed from 160 to 163.

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