A multicenter prospective cohort clinical study of a short-course glucocorticoid therapy regimen for glucocorticoid-dependent immune thrombocytopenia

• Register: ChiCTR
• Last refreshed on: 31 October 2022
• Main ID: ChiCTR2000030603
• Date of registration: 2020-03-08
• Prospective Registration: Yes
• Primary sponsor: The Second Affiliated Hospital of Kunming Medical University
• Public title: A multicenter prospective cohort clinical study of a short-course glucocorticoid therapy regimen for glucocorticoid-dependent immune thrombocytopenia
• Scientific title: A multicenter prospective cohort clinical study of a short-course glucocorticoid therapy regimen for glucocorticoid-dependent immune thrombocytopenia
• Date of first enrolment: 2020-05-01
• Target sample size: The short -course glucocorticoid group:65;The eltrombopag group:65;The rituximab group:65;Splenectomy group:65;The azathioprine group:65;The cyclosporine group:65;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=50345
• Study type: Interventional study
• Study design: Non randomized control
• Phase: 4

Countries of recruitment

China

Contacts

• Name: Zeping Zhou
• Affiliation: Department of Hematology, the Second Affiliated Hospital of Kunming Medical University

• Name: Honghui Wang
• Affiliation: Department of Hematology, the Second Affiliated Hospital of Kunming Medical University

Key inclusion & exclusion criteria

Inclusion criteria: 1. The patient signed the informed consent, and the subject fully understood and complied with the requirements of the study protocol and was willing to complete the study as planned.
2. Aged >= 18, male or female.
3. Multiple laboratory tests showed thrombocytopenia;
4. The spleen is not enlarged or only mildly enlarged;
5. The number of megakaryocytes in bone marrow examination was increased or normal, with mature disorders;
6. Glucocorticoid-dependent patients: prednisone of > 5mg/d (or equivalent of other glucocorticoids) is required continuously, or glucocorticoids are required frequently to maintain platelet >= 30 x 10^9/L or to avoid bleeding.
7. Patients with ITP with platelet count <= 30 x 10^9/L, or patients with platelet count > 30 x 10^9/L and bleeding symptoms.
Exclusion criteria: 1. Patients with secondary thrombocytopenia;
2. Pregnant and nursing women;
3. Have a history of allergy to adrenocorticosteroids;
4. Have participated in clinical trials of other new drugs within 3 months;
5. Abnormal liver and kidney functions;Defined as serum transaminase and bilirubin >= 1.5 times the upper limit of normal. Creatinine exceeding the upper limit of normal;
6. Antibody of second liver surface antigen, hepatitis c, HIV antibody (I + II), syphilis antibody positive;
7. Patients with diabetes, hypertension, glaucoma, gastrointestinal ulcer, herpes zoster, pulmonary infection and other conditions that are not suitable for glucocorticoid maintenance therapy;
8. Patients with poor compliance;
9. Those who cannot take contraceptive measures during the experiment;
10. Any other circumstances in which the investigator considers the patient unfit to participate in this trial.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Immune Thrombocytopenia

Intervention(s)

The short -course glucocorticoid group:treat with glucocorticoid;The eltrombopag group:treat with eltrombopag;The rituximab group:treat with rituximab;Splenectomy group:treat with splenectomy;The azathioprine group:treat with azathioprine;The cyclosporine group:treat with cyclosporine;

Primary Outcome(s)

platelate counts;

Secondary Outcome(s)

liver function;

Source(s) of Monetary Support

The Second Affiliated Hospital of Kunming Medical University

Ethics review

Status: Approved
Approval date: 31/12/2020
Contact:

Zheng Wang