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Randomized, Double-blind, Placebo-controlled Study With Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months

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Trial Profile

Randomized, Double-blind, Placebo-controlled Study With Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Jan 2025

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At a glance

  • Drugs Avatrombopag (Primary)
  • Indications Idiopathic thrombocytopenic purpura; Thrombocytopenia
  • Focus Registrational; Therapeutic Use
  • Acronyms AVA-PED-301
  • Sponsors Dova Pharmaceuticals

Most Recent Events

  • 12 Dec 2024 According to the Sobi media release, the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for avatrombopag (DOPTELET) for the treatment of thrombocytopenia in pediatric patients. The application, based on study results, and also FDA has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2025.
  • 03 Dec 2024 According to Sobi media release, data from this study will be presented in a oral presentation at at the 66th Annual Meeting of the American Society of Hematology (ASH) in San Diego, CA (USA) from the 7th - 10th of December 2024.
  • 04 Sep 2024 This trial has been completed in Hungary, according to European Clinical Trials Database record

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