A Two Part, Double-blind, Randomized, Placebo-controlled and Open-label Study to Investigate the Efficacy, Safety and Tolerability of Eltrombopag, a Thrombopoietin Receptor Agonist, in Pediatric Patients With Previously Treated Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP). PETIT2: Eltrombopag in PEdiatric Patients With Thrombocytopenia From ITP

Trial Profile

A Two Part, Double-blind, Randomized, Placebo-controlled and Open-label Study to Investigate the Efficacy, Safety and Tolerability of Eltrombopag, a Thrombopoietin Receptor Agonist, in Pediatric Patients With Previously Treated Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP). PETIT2: Eltrombopag in PEdiatric Patients With Thrombocytopenia From ITP

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Mar 2017

At a glance

  • Drugs Eltrombopag (Primary)
  • Indications Idiopathic thrombocytopenic purpura
  • Focus Registrational; Therapeutic Use
  • Acronyms PETIT2
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 07 Apr 2016 Results published in a Ligand Pharmaceuticals media release.
    • 07 Apr 2016 Results published in Novartis media release.
    • 07 Apr 2016 According to Novartis media release, the European Commission (EC) has approved Revolade (eltrombopag) for the treatment of pediatric (aged 1 year and above) chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (approval applies to all 28 EU member states, plus Iceland, Norway and Liechtenstein).
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