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.
Signed written informed consent
Age from 18 to 60 years old
Diagnosed with ITP and have a platelet count of <30 ×10^9/L on Day 1 (or within 48 hours prior to dosing on Day 1).
Patients who have no response or relapsed after splenectomy(at least more than 6 months). Or patients who have not been splenectomised and have either not responded to one or more prior therapies, or who have relapsed prior therapy.
Patients with any prior history of arterial or venous thrombosis, and with following risk factors: cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome.
Pregnant or lactating women;
Subjects is currently receiving treatment with another study medication.
Any laboratory or clinical evidence for HIV infection.
Parallel
eltrombopag combining rituximab
DrugAfter enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count \>250×10\^9/L, the eltrombopag will stop until the platelet count \<30×10\^9/L. All subjects receive single dose infusion of rituximab 375 mg/m(2) within 14 days after enrollment. Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12.
eltrombopag
DrugAfter enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count \>250×10\^9/L, the eltrombopag will stop until the platelet count \<30×10\^9/L. Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12.
Treatment response
Number of participants achieving a platelet count \>=30×10\^9/L and at least doubling of the baseline count at Week 4, Week 8, and Week 12 .
Drug efficacy
Number of participants achieving a platelet count \>=30×10\^9/L at week 4, week 8, and week 12 in ITP patients with positive autoantibody
Long-term treatment response
Number of participants achieving a platelet count \>=30×10\^9/L at week 16, week 20, and week 24.
Time to Response
Time to response is defined as time from the start of treatment to the first time of achieving a platelet count \>=30×10\^9/L and at least doubling of the baseline count during the whole 24 weeks.
Duration of response
Total duration of time a participant had a platelet count \>=30×10\^9/L
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Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
The Second Affiliated Hospital of Kunming Medical University
Collaborator
Henan Cancer Hospital
Collaborator
Tianjin Medical University Second Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Affiliated Hospital of Nantong University
Collaborator
