Swedish Orphan Biovitrum AB International (SOBI) pharmaceuticals is conducting a randomized, double-blind, placebo-controlled study with an open-label extension phase to evaluate the efficacy and safety of avatrombopag for the treatment of thrombocytopenia in pediatric subjects. The study is for participants between 1-17 years of age with a diagnosis of primary ITP for at least 6 months duration who have had an insufficient response to a previous treatment. Participants must have an average of two platelet counts less than 30×109/L with no single count greater than 35×109/L during the screening period. Avatrombopag is a thrombopoietin receptor agonist currently available for use in adults only with ITP.
France, Germany, Hungary, Poland, Russia, Turkey Ukraine, UK, and USA
https://clinicaltrials.gov/ct2/show/NCT04516967
Recruiting
