primary immune thrombocytopenia
Conditions
Interventions
experimental group:Cyclosporine A combined with eltrombopag
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18~75 years; 2. Meet the diagnostic criteria of adult primary ITP; 3. Glucocorticoid therapy is ineffective, intolerant or recurring, and second-line treatment is required; 4. Platelet count < 20 x 10^9/L; 5. ECOG score <= 2; 6. Patients who are willing to receive treatment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have a history of bone marrow stem cell abnormalities or observe other bone marrow abnormalities other than ITP-specific changes; 2. Combined with malignant tumors, active infections, other autoimmune diseases such as SLE, Sjogrens syndrome; 3. Received other ITP medications (including emergency treatment) within 2 weeks before the first administration (a stable dose of glucocorticoid, CsA, azathioprine, danazol, mycophenolate mofetil and other drugs before the first administration =4 Except for weeks); 4. Use Revolade (Eltrombopag) or Nplate (Romigrastim) or recombinant human thrombopoietin (rhTPO) or other c-Mpl (thrombopoietin receptor) stimulating drugs within 4 weeks before the first administration; 5. Received Decitabine within 4 weeks before the first dose; 6. Received splenectomy within 12 weeks before the first administration; 7. Received rituximab within six months before the first administration; 8. Have used the combination of CsA and Eltrombopag; 9. During the screening period, serum creatinine concentration> normal range, total bilirubin > 1.5 times the upper limit of normal range, alanine aminotransferase or aspartate aminotransferase> 3 times the upper limit of normal; 10. Have a history of blood clots or are using anticoagulant drugs; 11. Women during pregnancy and lactation; 12. Screening for hepatitis C antibodies, human immunodeficiency virus antibodies, or syphilis antibodies is positive; 13. Hepatitis B surface antigen positive or hepatitis B core antibody positive and HBV-DNA positive; 14. The researcher believes that it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Countries
China
Contacts
Public ContactJie Jin
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed