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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01760096
Date of registration: 01/01/2013
Prospective Registration: Yes
Primary sponsor: Institute of Hematology & Blood Diseases Hospital
Public title: 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)
Scientific title: 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)
Date of first enrolment: January 2013
Target sample size: 50
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT01760096
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
China
Contacts
Name:     yizhou zheng, doctor
Address: 
Telephone:
Email:
Affiliation:  Institute of Hematology & Blood Diseases Hospital
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Anemia, Hemolytic
Aplastic Anemia,
Bone Marrow Failure
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Paroxysmal Nocturnal Hemoglobinuria
Proteinuria
Thrombosis
Urination Disorders
Intervention(s)
Drug: cyclosporin A+Glucocorticoids
Drug: Glucocorticoids
Drug: Levamisole+cyclosporin A+Glucocorticoids
Primary Outcome(s)
Number of patients in each group in complete or partial remission [Time Frame: 6 months]
Secondary Outcome(s)
Secondary ID(s)
PNH-2013
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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