Primary Immune Thrombocytopenia (ITP) Clinical Trial
Official title:
A Multicenter, Randomized, Open-label StudyTo Compare The Efficacy And Safety Of TPO-RAs Combining Anti-CD 20 Monoclonal Antibody Versus TPO-RAs in Persistent or Chronic Pediatric ITP Patients Who Failed or Relapse After Glucocorticoid Therapy
This multicenter randomized, open-label study aim to compare the efficacy and safety of TPO-RAs combining anti-CD 20 monoclonal antibody with TPO-RAs in China pediatric ITP patients .This study will be conducted in persistent or chronic pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.
The primary objective of this study was to evaluate the efficacy and safety of TPO-RAs combining anti-CD 20 monoclonal antibody treating previously treated pediatric ITP patients compared to TPO-RAs. The secondary objective was to evaluate the efficacy of TPO-RAs combining anti-CD 20 monoclonal antibody in pediatric ITP patients with positive autoantibody compared to TPO-RAs.In addition, health-related quality of life (HRQoL) measure was assessed in all participants. 166 eligible subjects were randomized to either TPO-RAs combining anti-CD 20 monoclonal antibody or TPO-RAs treatment in 1:1 ratio. 83 enrolled patients are randomly picked up to take TPO-RAs combining with anti-CD 20 monoclonal antibody at the indicated dose. 83 enrolled patients are randomly picked up to take TPO-RAs at the indicated dose. Three TPO-RAs could be used in this study, including eltrombopag, hetrombopag and avatrombopag. The initial dose of eltrombopag administration was an oral 37.5 mg (6-11 years old) or 50 mg (12-17 years old) once daily in all participants. The initial dose of hetrombopag administration was an oral 3.75 mg (6-11 years old) or 5mg (12-17 years old) once daily in all participants. The initial dose of avatrombopag administration was an oral 10 mg (<30kg) or 20mg (≥30kg) once daily in all participants.The dose of TPO-RAs was adjusted according to the subject platelet count during the period from week 1 to week 24. Two kinds of anti-CD 20 monoclonal antibody could be used in this study, including Rituximab and Ortuzumab.Subjects in TPO-RAs combining anti-CD 20 monoclonal antibody treatment group received single dose infusion of Rituximab 375 mg/m2 within 14 days after enrollment. Subjects weighing less than 30kg will be given Rituximab 100 mg once a week for four times. Ortuzumab at 1000mg/ dose is also recommended for subjects weighing 45kg or greater. Ps.Participants in the TPO-RAs monotherapy group who have platelet count < 20×10^9/L or significant skin and mucosal bleeding at the end of 12 weeks of treatment will be given a single dose of Rituximab 375mg/m2.Ortuzumab at 1000mg/ dose is also recommended for subjects weighing 45kg or greater. ;
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