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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: |
NCT01642979 |
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Date of registration:
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14/07/2012 |
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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 of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria
PNH-2012 |
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Scientific title:
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Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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120 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01642979 |
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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 classic Paroxysmal Nocturnal Hemoglobinuria
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
5. patient who terminate ealy from levamisole study
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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Bone Marrow Failure
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Urination Disorders
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Anemia, Hemolytic
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Hemoglobinuria, Paroxysmal
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Thrombosis
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Paroxysmal Nocturnal Hemoglobinuria
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Aplastic Anemia,
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Hemoglobinuria
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Proteinuria
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Intervention(s)
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Drug: cyclosporin A+Glucocorticoids
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Drug: Glucocorticoids
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Drug: Levamisole+cyclosporin A+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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Secondary Outcome(s)
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Side effects
[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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