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First patient dosed in phase III study with Doptelet for treatment of ITP in children. SOBI

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Published:13th Mar 2021
Swedish Orphan Biovitrum AB (publ) (Sobi™) announced that the first patient has been dosed with Doptelet (avatrombopag), a thrombopoietin receptor agonist (TPO-RA), for treatment of immune thrombocytopenia (ITP) in pediatric patients. This phase III study, the first the evaluate avatrombopag in children, will evaluate efficacy, safety, and pharmacokinetics of avatrombopag in the treatment of pediatric subjects with ITP. About AVA-PED-301 Study : AVA-PED-301 is a phase III study evaluating the efficacy, safety, and pharmacokinetics of avatrombopag in the treatment of pediatric subjects with ITP. Eligible pediatric subjects with platelet counts <30×109 l will enter a 12-week double-blind phase followed by an open-label extension phase up to 2 years in duration. this study will enroll a total of 72 pediatric subjects (aged greater than 1 to less than 18 years of age) in 9 countries. subjects will be randomized to blinded therapy of either avatrombopag or placebo in a 3:1 ratio. enrollment into the study will be staggered by descending age cohort, with a safety and pharmacokinetic review conducted before opening the next cohort for enrolment.>
Condition: Thrombocytopenia
Type: drug

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