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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: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jan 2026

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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

  • 15 Jan 2026 Status changed from active, no longer recruiting to completed.
  • 01 Oct 2025 Planned primary completion date changed from 14 Aug 2023 to 28 Oct 2025.
  • 25 Jul 2025 According to the Sobi media release, the U.S. Food and Drug Administration (FDA) approved Doptelet (avatrombopag) for the treatment of thrombocytopenia in pediatric patients one year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a prior therapy, based on results from this study.

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