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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: 14 Aug 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

  • 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.
  • 25 Jul 2025 According to the Sobi media release, Rachael Grace is the lead investigator of this study
  • 25 Jul 2025 Primary endpoint (Alternative Primary: Platelet Response) has been met, according to the results published in the Sobi media release.

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