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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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15 March 2021 |
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Main ID: |
ChiCTR2000041485 |
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Date of registration:
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2020-12-27 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Danazol after no response to cyclosporin in transfusion independent aplastic anemia: a prospective study
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Scientific title:
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Efficacy of Danazol after no response to cyclosporin in transfusion independent aplastic anemia: a prospective study |
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Date of first enrolment:
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2021-01-01 |
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Target sample size:
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experimental group:152;control group:76; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=66020 |
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Study type:
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Interventional study |
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Study design:
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Non randomized control
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Phase:
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4
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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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Shi Jun
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Address:
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288 Nanjing Road, Heping District, Tianjin, China
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Telephone:
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+86 13752253515 |
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Email:
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shijun@ihcams.ac.cn |
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Affiliation:
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Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College |
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Name:
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Zhao Jingyu
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Address:
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288 Nanjing Road, Heping District, Tianjin, China
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Telephone:
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+86 13752253515 |
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Email:
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zhaojingyu@ihcams.ac.cn |
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Affiliation:
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Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) Aged > 14 years.
2) Aplastic anemia is clearly diagnosed from the peripheral blood smear and bone marrow examination.
3) Transfusion independence with ANC > 0.5 x 10^9/L.
4) Never received immunosuppressive therapy(IST) before or received IST less than 4weeks.
5) Never received androgen therapy before or received androgen therapy less than 4weeks.
6) Can fully understand and voluntarily sign informed consent forms.
Exclusion criteria: 1) Aplastic anemia patients with PNH clones.
2) Diagnosed with congenital aplastic anemia or other congenital bone marrow failure.
3) Patients with abnormal liver function, i.e. ALT or AST > 2.5ULN, or TB > 2ULN, or CrCl < 60 ml/min/1.73 m^2.
4) Experienced a solid tumor or received radiation therapy/chemotherapy.
5) Nursing women.
6) Inability to understand or to follow study procedures.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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transfusion independent aplastic anemia
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Intervention(s)
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experimental group:Cyclosporine combined with danazol;control group:Cyclosporine;
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Primary Outcome(s)
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superior remission rate;
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Secondary Outcome(s)
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rate of progression;relapse rate;
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Source(s) of Monetary Support
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self-raised
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Ethics review
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Status: Approved
Approval date: 03/12/2020
Contact:
ec@ihcams.ac.cn
Zhang Yali
+86 22-23909095
ec@ihcams.ac.cn
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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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