Cyclosporine A combined with eltrombopag in the treatment for primary immune thrombocytopenia: a prospective, multicenter, single-arm, open clinical study

• Register: ChiCTR
• Last refreshed on: 12 April 2021
• Main ID: ChiCTR2000040991
• Date of registration: 2020-12-16
• Prospective Registration: Yes
• Primary sponsor: The First Affiliated Hospital, College of Medicine, Zhejiang University
• Public title: Cyclosporine A combined with eltrombopag in the treatment for primary immune thrombocytopenia: a prospective, multicenter, single-arm, open clinical study
• Scientific title: Cyclosporine A combined with eltrombopag in the treatment for primary immune thrombocytopenia: a prospective, multicenter, single-arm, open clinical study
• Date of first enrolment: 2022-03-02
• Target sample size: experimental group:28;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=65311
• Study type: Interventional study
• Study design: Single arm
• Phase: 4

Countries of recruitment

China

Contacts

• Name: Jie Jin
• Affiliation: The First Affiliated Hospital, College of Medicine, Zhejiang University

• Name: Chao Hu
• Affiliation: The First Affiliated Hospital, College of Medicine, Zhejiang University

Key inclusion & exclusion 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: 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.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

primary immune thrombocytopenia

Intervention(s)

experimental group:Cyclosporine A combined with eltrombopag;

Primary Outcome(s)

Overall response rate;

Secondary ID(s)

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Source(s) of Monetary Support

self-raised

Ethics review

Status: Approved
Approval date: 23/09/2020
Contact:

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Huili Zhou

[phone]

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