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.
• 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.
• Subjects treated with previous therapy(including but not limited to corticosteroid, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must have been completed prior to randomization, or must not be increasing a dose after enrollment.
• No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) \>450msec or QTc \>480 for patients with a Bundle Branch Block.
• No pre-existing infection within the last 1 months(including but not limited to pulmonary infection)
• Laboratory tests for coagulation function showed that prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) no exceed normal by more than 20%. No history of clotting disorder, other than ITP.
• White blood cell count, neutrophil absolute value, hemoglobin, within the reference range, with the following exceptions:
‣ Hemoglobin: females and males 10.0 g/dl are eligible for inclusion,
⁃ Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion
⁃ The following blood chemistry test result no exceed normal by more than 20%:alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine,serum albumin must not be below the lower limit of normal (LLN) by more than 10%.
⁃ Subject is non-childbearing potential of childbearing potential and use acceptable methods of contraception throughout the study.
⁃ Subjects fully understand and are able to comply with the requirements of the research protocol and are willing to complete the study as planned.