Trial Profile
A Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of AMG 531 in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic Purpura
Status:
Completed
Phase of Trial:
Phase I/II
Latest Information Update: 02 Feb 2021
Price :
$35
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At a glance
- Drugs Romiplostim (Primary)
- Indications Idiopathic thrombocytopenic purpura; Thrombocytopenia
- Focus Adverse reactions
- 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.
- 10 Nov 2017 According to an amgen media release, The CHMP of the European Medicines Agency (EMA) has adopted a positive opinion to expand the current indication for Nplate (romiplostim) to include the treatment of idiopathic thrombocytopenic purpura for patients one year of age and older.CHMP opinion was based on five studies including 4 completed studies (a Phase 3, a Phase 1/2 placebo-controlled study, two long-term safetyand efficacy studies) and one ongoing long-term safety and efficacy study.
- 04 Jul 2014 New trial record