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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: |
NCT01760096 |
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Date of registration:
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01/01/2013 |
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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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Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)
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Scientific title:
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Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013) |
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Date of first enrolment:
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January 2013 |
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Target sample size:
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50 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01760096 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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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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yizhou zheng, doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Hematology & Blood Diseases Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Clinical and biochemical signs of Subclinical Paroxysmal Nocturnal Hemoglobinuria and
PNH in the setting of another bone marrow failure syndromes
2. Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry
data
3. patient should complete levamisole study for at least half a year
Exclusion Criteria:
1. Active infection which requires antibiotic treatment
2. Pregnant or lactating women
3. Epilepsy and mental illness
4. Kidney and liver function abnormal
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hemoglobinuria, Paroxysmal
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Anemia, Hemolytic
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Paroxysmal Nocturnal Hemoglobinuria
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Urination Disorders
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Thrombosis
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Bone Marrow Failure
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Proteinuria
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Aplastic Anemia,
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Hemoglobinuria
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Intervention(s)
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Drug: Levamisole+cyclosporin A+Glucocorticoids
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Drug: cyclosporin A+Glucocorticoids
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Drug: Glucocorticoids
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Primary Outcome(s)
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Number of patients in each group in complete or partial remission
[Time Frame: 6 months]
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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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