About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- eltrombopag combining rituximab
- eltrombopag
Treatment groups
Sponsors and collaborators
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