A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Determine the Safety and Efficacy of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)
Phase of Trial: Phase III
Latest Information Update: 16 Jun 2019
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At a glance
- Drugs Romiplostim (Primary)
- Indications Idiopathic thrombocytopenic purpura; Thrombocytopenia
- Focus Registrational; Therapeutic Use
- Sponsors Amgen
- 14 Dec 2018 According to an Amgen media release, the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Nplate (romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy, based on the results of two placebo-controlled studies- Phase 3 and Phase 1/2.
- 19 Apr 2016 Results published in an Amgen media release.
- 18 Apr 2016 Results published in the Lancet.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History