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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-OPB-16007730 |
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Date of registration:
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2016-01-09 |
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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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Mycophenolate Mofetil Treatment of Neuromyelitis Optica in Chinese Patients (MONICA)
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Scientific title:
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Mycophenolate Mofetil Treatment of Neuromyelitis Optica in Chinese Patients (MONICA) |
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Date of first enrolment:
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2016-01-01 |
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Target sample size:
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Case series:100; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=12126 |
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Study type:
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Observational study |
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Study design:
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historical control
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Phase:
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Post-market
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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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Qiu Wei
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Address:
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600 Tianhe Road, Tianhe District, Guangzhou, China
510630
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Telephone:
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+86 15899968330 |
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Email:
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qw9406@gmail.com |
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Affiliation:
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The third affiliated hospital,Sun Yat-sen university |
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Name:
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Qiu Wei
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Address:
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600 Tianhe Road, Tianhe District, Guangzhou, China
510630
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Telephone:
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+86 15899968330 |
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Email:
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qw9406@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: (1) 2006 NMO diagnostic criteria or NMOSD criteria;
(2) serum NMO-IgG(+) (HEK 293 cells transfection method);
(3) aged 18-65 years old, men and women;
(4) relapse frequency: two or more attacks in the prior two years, one or more in the recent one year;
(5) EDSS less than 7.0, and at least one eye visual acuity of 20/100;
(6) written informed consent signed.
Exclusion criteria: (1) using other immunosuppressants, such as cyclophosphamide, cyclosporin A,azathioprine, methotrexate;
(2) with concomitant diseases: transaminase 2 times more than normal ceiling; The WBC <4*10^9/L, HGB <80 g/L, PLT <100*10^9/L;
(3) with severe cardiovascular, liver, kidney and other important organs and blood, endocrine system diseases;
(4) with immunodeficiency, with uncontrolled infections and active gastrointestinal diseases (such as stomach ulcers, etc.);
(5) women of childbearing agewith postive urine pregnancy test, lactatin;
(6) being allergic to mycophenolate mofetil and prednisone.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neuromyelitis optica
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Intervention(s)
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Case series:Mycophenolate Mofetil;
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Primary Outcome(s)
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annual relapse rate;
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Source(s) of Monetary Support
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Manufacturer of sponsorship
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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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