eltrombopag combining rituximab: After 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: After 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
1. Signed written informed consent
2. Age from 18 to 60 years old
3. 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).
4. 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.
5. 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.
6. 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.
7. No pre-existing infection within the last 1 months(including but not limited to pulmonary infection)
8. 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.
9. 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
10. 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%.
11. Subject is non-childbearing potential of childbearing potential and use acceptable methods of contraception throughout the study.
12. Subjects fully understand and are able to comply with the requirements of the research protocol and are willing to complete the study as planned.
Exclusion Criteria:
1. Patients with any prior history of arterial or venous thrombosis, and with following risk factors: cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome.
2. Pregnant or lactating women;
3. Subjects is currently receiving treatment with another study medication.
4. Any laboratory or clinical evidence for HIV infection.
5. Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. Laboratory test shows positive serology for Hepatitis C or Hepatitis B (HB). In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
6. History of platelet aggregation that prevents reliable measurement of platelet counts.
7. Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.
Primary outcome measure(s)
Treatment response — From the start of study treatment (Day 1) up to the end of week 12. 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 .
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin
China
Recruiting
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.