Primary Immune Thrombocytopenia (ITP) Clinical Trial
Official title:
A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients
This multicenter randomized, open-label study aimed to compare the efficacy and safety of eltrombopag combining rituximab with eltrombopag in China adult ITP patients .This study was be conducted in adult ITP patients who had not responded to or had relapsed after previous treatment of ITP, including first line therapy and /or splenectomy.
The primary objective of this study was to evaluate the efficacy and safety of eltrombopag
combining rituximab treating previously treated ITP patients compared to eltrombopag. The
secondary objective was to evaluate the efficacy of eltrombopag combining rituximab in ITP
patients with positive autoantibody compared to eltrombopag .In addition, health-related
quality of life (HRQoL) measure was assessed in all participants.
224 eligible subjects were randomized to either eltrombopag combining rituximab or
eltrombopag treatment in 1:1 ratio. 112 enrolled patients are randomly picked up to take
eltrombopag combining with rituximab at the indicated dose. 112 enrolled patients are
randomly picked up to take eltrombopag at the indicated dose.
The initial dose of eltrombopag administration was an oral 75 mg once daily in all
participants .The dose of eltrombopag was adjusted according to the subject platelet count
during the period from week 1 to week 24.
Subjects in eltrombopag combining rituximab treatment group received single dose infusion of
rituximab 375 mg/m(2) within 14 days after enrollment.
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|---|---|---|---|
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