Status:
UNKNOWN
Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
The Second Affiliated Hospital of Kunming Medical University
Henan Cancer Hospital
Conditions:
Primary Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 a...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
- History of platelet aggregation that prevents reliable measurement of platelet counts.
- Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 10 2022
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT04518475
Start Date
August 10 2020
End Date
August 10 2022
Last Update
August 19 2020
Active Locations (1)
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1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China