The purpose of this study is to investigate the efficacy, safety of Hetrombopag in children with previously treated chronic immune thrombocytopenia who are between 6 and 17 years of age. This is a 2 part study. In part A, patients will receive Hetrombopag for 8 weeks. In part B, all patients will receive Hetrombopag for 24 weeks.
This is a two-part, double-blind, randomized, placebo-controlled, and open-label Phase III study to investigate the efficacy, safety of Hetrombopag in pediatric patients with previously treated chronic ITP. In Part A, patients will receive Hetrombopag for 8 weeks. After completing Part A, patients will begin Part B, in which they will be randomized to receive Hetrombopag or placebo in a 12 week double-blind, placebo-controlled treatment period, following an open-label 12 week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Thrombopoietin receptor agonist
Placebo with no active pharmaceutical ingredient
Beijing children's hospital .Capital medical university
Beijing, Beijing Municipality, China
the main parameters in population PK/PD modeling in Part A
Peak Plasma Concentration (Cmax)
Time frame: from baseline to Week 2
the proportion of patients with a platelet count ≥50×10^9/L at week 10.
efficacy in part B
Time frame: from baseline to Week 10
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