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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ClinicalTrials.gov Identifier: NCT01760096 |
Recruitment Status : Unknown
Verified January 2013 by Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 3, 2013
Last Update Posted : January 3, 2013
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Condition or disease | Intervention/treatment | Phase |
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Paroxysmal Nocturnal Hemoglobinuria Hemoglobinuria Hemoglobinuria, Paroxysmal Proteinuria Urination Disorders Thrombosis Bone Marrow Failure Aplastic Anemia, Anemia, Hemolytic | Drug: Levamisole+cyclosporin A+Glucocorticoids Drug: cyclosporin A+Glucocorticoids Drug: Glucocorticoids | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official 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) |
Study Start Date : | January 2013 |
Estimated Primary Completion Date : | July 2016 |
Estimated Study Completion Date : | July 2017 |

Arm | Intervention/treatment |
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Experimental: Levamisole+cyclosporin A+Glucocorticoids
Levamisole+cyclosporin A+Glucocorticoids
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Drug: Levamisole+cyclosporin A+Glucocorticoids
Levamisole 2.5mg/kg every other day cyclosporin A 3-5mg/kg every other day Glucocorticoids0.25 mg/kg every day(prednisone)
Other Names:
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Active Comparator: cyclosporin A+Glucocorticoids
cyclosporin A+Glucocorticoids
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Drug: cyclosporin A+Glucocorticoids
cyclosporin A 3-5mg/kg every day Glucocorticoids0.25mg/kg every day(prednisone)
Other Names:
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Active Comparator: Glucocorticoids
Glucocorticoids
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Drug: Glucocorticoids
Glucocorticoids0.25mg/kg every day(prednisone) |
- Number of patients in each group in complete or partial remission [ Time Frame: 6 months ]she got blood transfusion-independent,the hemoglobin became higher

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical and biochemical signs of Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes
- Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
- patient should complete levamisole study for at least half a year
Exclusion Criteria:
- Active infection which requires antibiotic treatment
- Pregnant or lactating women
- Epilepsy and mental illness
- Kidney and liver function abnormal

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760096
China, Tianjin | |
Institute of Hematology & Blood Diseases Hospital, | |
Tianjin, Tianjin, China, 300020 |
Principal Investigator: | yizhou zheng, doctor | Institute of Hematology & Blood Diseases Hospital |
Publications:
Responsible Party: | Yizhou Zheng, Vice director of the therapeutic centre of anemic diseases, Institute of Hematology & Blood Diseases Hospital |
ClinicalTrials.gov Identifier: | NCT01760096 |
Other Study ID Numbers: |
PNH-2013 |
First Posted: | January 3, 2013 Key Record Dates |
Last Update Posted: | January 3, 2013 |
Last Verified: | January 2013 |
Paroxysmal Nocturnal Hemoglobinuria Anemia Hematologic Diseases bone marrow failure |
Immunologic Factors Physiological Effects of Drugs Levamisole cyclosporine A |
Proteinuria Hemoglobinuria Urination Disorders Thrombosis Anemia Anemia, Aplastic Hemoglobinuria, Paroxysmal Pancytopenia Anemia, Hemolytic Hematologic Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Bone Marrow Diseases Urologic Diseases |
Urological Manifestations Myelodysplastic Syndromes Cyclosporine Levamisole Cyclosporins Glucocorticoids Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents |