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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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12 December 2020 |
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Main ID: |
NCT03918265 |
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Date of registration:
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16/04/2019 |
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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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Tacrolimus Treatment for Refractory Autoimmune Cytopenia
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Scientific title:
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Tacrolimus Treatment for Refractory Autoimmune Cytopenia |
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Date of first enrolment:
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May 4, 2019 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03918265 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 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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Bing Hang, 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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Peking Union Medical College Hospital |
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Name:
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Ruoxi Zhang, MD |
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Address:
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Telephone:
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+86 18510064839 |
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Email:
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rx_zh15@163.com |
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Affiliation:
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Name:
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Ruoxi Zhang, M.D. |
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Address:
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Telephone:
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+86 18510064839 |
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Email:
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rx_zh15@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Refractory autoimmune cytopenia, including autoimmune hemolytic anemia, pure red cell
aplasia, Evans syndrome.
- 18-80 years old.
- No response or intolerant to first and second line therapies.
- ECOG Performance Status of 0-2
- Written informed consent.
Exclusion Criteria:
- Other diseases which might cause hematological abnormalities.
- Response and well tolerate to first or second line therapy.
- Patients who are under 18-year-old or over 80-year-old.
- Pregnant or lactating.
- Patients unwilling to or unable to comply with the protocol.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Evans Syndrome
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Pure Red Cell Aplasia
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Autoimmune Hemolytic Anemia
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Intervention(s)
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Drug: Tacrolimus
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Primary Outcome(s)
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Hemoglobin level
[Time Frame: 6 months]
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Platelet count
[Time Frame: 6 months]
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Secondary Outcome(s)
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Platelet count
[Time Frame: 2 years]
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Hemoglobin level
[Time Frame: 2 years]
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Secondary ID(s)
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tacrolimus-2
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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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