At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo-controlled Study With Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months
In Brief
A Phase 3 clinical trial evaluating Avatrombopag and Placebo for Immune Thrombocytopenia. Completed, enrolled 75 participants across 62 sites in 9 countries.
Signals
Detailed Summary
A Phase 3b Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months
Study Details
Timeline
Arms & Interventions
Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks
Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks
Investigational product administered orally for up to 2 years.
Interventions
Oral avatrombopag tablet or sprinkle capsule
Placebo comparator tablet or sprinkle capsule