A clinical trial to evaluate the efficacy and safety of corticosteroids combined with cyclosporin A in the treatment of primary immune thrombocytopenia

• Register: ChiCTR
• Last refreshed on: 8 January 2018
• Main ID: ChiCTR-OON-17014165
• Date of registration: 2017-12-27
• Prospective Registration: Yes
• Primary sponsor: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
• Public title: A clinical trial to evaluate the efficacy and safety of corticosteroids combined with cyclosporin A in the treatment of primary immune thrombocytopenia
• Scientific title: A clinical trial to evaluate the efficacy and safety of corticosteroids combined with cyclosporin A in the treatment of primary immune thrombocytopenia
• Date of first enrolment: 2018-01-01
• Target sample size: one:100;two:100;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=23843
• Study type: Observational study
• Study design: Non randomized control
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Donghua Zhang
• Affiliation: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

• Name: Donghua Zhang
• Affiliation: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged between 18 and 65, male or female;
2. Primary ITP patients diagnosed with consensus of Chinese experts on the diagnosis and treatment of adult primary immune thrombocytopenia (version 2016);
3. Platelet counts at enrollment <30*10^9/L
Exclusion criteria: Subjects will be excluded if they have any of the following conditions: malignancy, connective tissue diseases, seropositive detection of human immunodeficiency virus, detectable HBV DNA, detectable HCV RNA, pregnancy or lactation, active infection that can't be controlled by antibiotics, uncontrolled hypertension (blood pressure is still higher than 140 / 90mmHg after taking oral antihypertensive agents), diabetes, New York Heart Association functional classes III and IV, active peptic ulcer, adrenocortical hyperfunction, during the recovery phase of trauma, ALT or AST is more than 2.5 times the upper limit of normal, total bilirubin is more than 1.5 times the upper limit of normal, renal insufficiency (elevated serum creatinine, hyperkalemia), psychosis, patients who are intolerant to corticosteroids or cyclosporin A, other situations not approved by researchers.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Immune Thrombocytopenia

Intervention(s)

one:Corticosteroids;two:Corticosteroids combined with Cyclosporin A ;

Primary Outcome(s)

Platelet counts;

Secondary Outcome(s)

Tregs subsets;

Source(s) of Monetary Support

self-financing

Ethics review

Status: Approved
Approval date: 05/12/2017
Contact:

The medical ethics committee of tongji hospital affiliated to tongji medical school of huazhong university of science and technology