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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00399971 |
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Date of registration:
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14/11/2006 |
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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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Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic Anemia
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Scientific title:
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Phase I/II Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic Anemia |
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Date of first enrolment:
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November 2002 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00399971 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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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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Demao Yang, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shenzhen Zhongxing Yangfan Biotech Co. Ltd. |
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Name:
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Demao Yang, PhD |
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Address:
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Telephone:
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86 755 2603 1580 |
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Email:
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dyang@yangfan-biotech.com |
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Affiliation:
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Name:
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Yang Xiao, MD, PhD |
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Address:
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Telephone:
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86 1390 221 3175 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical Diagnosis of Idiopathic Aplastic Anemia
- Not Eligible for Bone Marrow Transplantation
- Not Responsive to Conventional Immunosuppressive Therapy
Exclusion Criteria:
- Leukemia or MDS or PNH or Fanconi's Disease
- pregnancy
- Allergic to Blood Product
- Severe Hypertension or Heart Disease
- Liver or Kidney Disease
Age minimum:
10 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia, Aplastic
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Intervention(s)
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Drug: Ex vivo immunotherapy
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Procedure: Ex Vivo Immunotherapy
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Primary Outcome(s)
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Survival
[Time Frame: 2 years]
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Secondary Outcome(s)
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Hematopoietic Activities in Bone Marrow
[Time Frame: 2 years]
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Hematological Parameters
[Time Frame: 2 years]
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Quality of Life
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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