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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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6 November 2017 |
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Main ID: |
ChiCTR-ONC-17013230 |
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Date of registration:
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2017-11-03 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A single center, one-arm, and open clinical study of PKA agonist (aminophylline) with conventional treatment for chronic or refractory primary immune thrombocytopenia
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Scientific title:
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A single center, one-arm, and open clinical study of PKA agonist (aminophylline) with conventional treatment for chronic or refractory primary immune thrombocytopenia |
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Date of first enrolment:
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2017-05-20 |
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Target sample size:
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Case series:60; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=22168 |
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Study type:
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Observational study |
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Study design:
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Case series
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Phase:
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New Treatment Measure Clinical Study
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Countries of recruitment
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China
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Contacts
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Name:
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Kesheng Dai
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Address:
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708 Renmin Road, Suzhou, Jiangsu, China
215000
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Telephone:
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+86 18662272437 |
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Email:
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kdai@suda.edu.cn |
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Affiliation:
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The First Affiliated Hospital of Soochow University |
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Name:
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Qingya Cui
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Address:
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708 Renmin Road, Suzhou, Jiangsu, China
215000
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Telephone:
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+86 15850130251 |
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Email:
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cuiqingyajun@163.com |
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Affiliation:
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The First Affiliated Hospital of Soochow University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients aged between 11 to 65 years male and female;
2. The clinical diagnosis is refractory or chronic ITP patients which need treatment (platelet count < 30 x 10^9/L);
3. Patients are dependent on or not response to glucocorticoids; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) at least 3 months and the platelet is not increasing in the last 4 weeks;
4. Understand the research program and voluntarily signed informed consent.
Exclusion criteria: 1. Patients participated in other clinical trials in one month;
2. Pregnancy or breastfeeding women;
3. Megakaryophthisis;
4. The following biochemical indexes: ALT/AST is greater than 1.5 times the normal limit, total bilirubin, serum creatinine and alkaline phosphatase 1.2 times greater than normal;
5. Patients received with mabthera and splenectomy treatment in six monthes;
6. HIV infection, positive hepatitis C antibody or positive hepatitis B surface antigen;
7. Patients with arrhythmia;
8. Poor control of hypertension or active digestive tract ulcer;
9. Uncontrolled convulsive disease or mental illness;
10. Allergic to aminophylline;
11. Receiving the medicine of rofluorist.
Age minimum:
11
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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primary immune thrombocytopenia
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Intervention(s)
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Case series:PKA agonist (aminophylline) treats chronic or refractory primary immune thrombocytopenia;
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Primary Outcome(s)
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the effectiveness;
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Secondary Outcome(s)
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safety;
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Source(s) of Monetary Support
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National Natural Science Foundation of China.
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Ethics review
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Status: Approved
Approval date: 10/05/2017
Contact:
sdfyec@163.com
Li Zhou
+86 0512-67780081
sdfyec@163.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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