Protocol No.: OCR39636
Sponsor Protocol No.: AVA-PED-301
Protocol Title.: Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months
Principal Investigator: Wynn, Tung
Objective: 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
Description: Subjects will be randomized in to blinded therapy of avatrombopag or placebo in a 3:1 ratio for a period of 12 weeks. Subjects who complete the 12 week treatment period and are eligible may continue to the open label extension phase which will last 2 years.
Phase: Phase III
Age Group: Children
Age: 1 Year - 17 Years
Active Comparator: Experimental: AvatrombopagStudy is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks
Placebo Comparator: Placebo Comparator:PlaceboStudy is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks
Detailed Eligibility: Inclusion Criteria: - Male or female participants ≥1 and <18 years of age at Screening and Baseline with a diagnosis of primary ITP for ≥6 months duration and has had an insufficient response to a previous treatment, in the opinion of the Investigator. - Participant has an average of 2 platelet counts 35×10^9/L in the screening period Exclusion Criteria: - Participants must not have a known history of secondary ITP, any history of arterial or venous thrombosis, including partial or complete thrombosis, known inherited thrombocytopenia, a history of myelodysplastic syndrome (MDS) or known history of congenital heart abnormalities or arrhythmias.
Contact:Mona Brenda Sayedul Huq