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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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18 April 2017 |
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Main ID: |
ChiCTR-IPR-14005720 |
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Date of registration:
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2014-12-17 |
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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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A single center, Randomized controlled, opened clinical reserch for evaluating the effectiveness of recombinant human thrombopoietin combined with immunosuppressive therapy in the treatment of newly diagnosed acquired severe aplastic anemia
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Scientific title:
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A single center, Randomized controlled, opened clinical reserch for evaluating the effectiveness of recombinant human thrombopoietin combined with immunosuppressive therapy in the treatment of newly diagnosed acquired severe aplastic anemia |
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Date of first enrolment:
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2015-01-01 |
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Target sample size:
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TPO:86;Ciclosporine:86; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=10126 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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I (Phase I 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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Zhang Fengkui
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Address:
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288 Nanjing Road, Tianjin
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Telephone:
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+86 022 23909229 |
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Email:
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zhfk@hotmail.com |
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Affiliation:
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Blood Diseases Hospital, Chinese Academy of Medical Sciences |
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Name:
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Zhang Fengkui
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Address:
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288 Nanjing Road, Tianjin
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Telephone:
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+86 022 23909229 |
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Email:
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zhfk@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. age 18~75 years old;
2. ECOG score 0~2;
3. newly diagnosed SAA;
4. be not eligible for HSCT, and willing for treatment with ATG+CSA;
5. without severe organ damage;
6. sign informed consent.
Exclusion criteria: 1. congenital bone marrow failur;
2. clonal abnomality;
3. uncontroled infection;
4. severe heart, kidney, liver disease;
5. other tumor;
6. in breast feeding or pregnacy period;
7. history of thrombosis.
Age minimum:
18
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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severe aplastic anemia
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Intervention(s)
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TPO:rTPO;Ciclosporine:Ciclosporine;
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Primary Outcome(s)
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blood routine;bone marrow exmination;blood biochemistry;
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Source(s) of Monetary Support
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Nil
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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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