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Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria.
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal disorder of the hematopoietic stem cell characterized by intravascular hemolysis, hemoglobinuria, anemia, and thrombosis, Patients may be at high risk of thrombosis and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts,because the manifestation and pathologic processes are complicate,the treatment is very difficult,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levamisole+cyclosporin A+Glucocorticoids | Experimental | Levamisole+cyclosporin A+Glucocorticoids |
|
| cyclosporin A+Glucocorticoids | Active Comparator | cyclosporin A+Glucocorticoids |
|
| Glucocorticoids | Active Comparator | Glucocorticoids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levamisole+cyclosporin A+Glucocorticoids | Drug | Levamisole 2.5mg/kg every other day cyclosporin A 1.5-2.5mg/kg every other day Glucocorticoids0.5-1mg/kg every day(prednisone) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients in each group in complete or partial remission | she got blood transfusion-independent,the hemoglobin became higher | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yizhou zheng, doctor | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, | Tianjin | Tianjin Municipality | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16051736 | Background | Parker C, Omine M, Richards S, Nishimura J, Bessler M, Ware R, Hillmen P, Luzzatto L, Young N, Kinoshita T, Rosse W, Socie G; International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005 Dec 1;106(12):3699-709. doi: 10.1182/blood-2005-04-1717. Epub 2005 Jul 28. No abstract available. |
| Label | URL |
|---|---|
| CBD | View source |
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|
| cyclosporin A+Glucocorticoids | Drug | cyclosporin A 1.5-2.5mg/kg every day Glucocorticoids0.5-1mg/kg every day(prednisone) |
|
|
| Glucocorticoids | Drug | Glucocorticoids 0.5-1mg/kg every day(prednisone) |
|
| ID | Term |
|---|---|
| D006457 | Hemoglobinuria, Paroxysmal |
| D006456 | Hemoglobinuria |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D013927 | Thrombosis |
| D000080983 | Bone Marrow Failure Disorders |
| D000741 | Anemia, Aplastic |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007978 | Levamisole |
| D016572 | Cyclosporine |
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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