Cyclosporine a (DrugBank: Cyclosporine)
10 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 19 | ライソゾーム病 | 4 |
| 20 | 副腎白質ジストロフィー | 2 |
| 36 | 表皮水疱症 | 1 |
| 49 | 全身性エリテマトーデス | 1 |
| 50 | 皮膚筋炎／多発性筋炎 | 10 |
| 53 | シェーグレン症候群 | 4 |
| 58 | 肥大型心筋症 | 1 |
| 60 | 再生不良性貧血 | 19 |
| 234 | ペルオキシソーム病（副腎白質ジストロフィーを除く。） | 1 |
| 283 | 後天性赤芽球癆 | 2 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01626092 (ClinicalTrials.gov) | July 11, 2012 | 20/6/2012 | Reduced-Intensity Hematopoietic Stem Cell Transplant for High Risk Lysosomal and Peroxisomal Disorders | Treatment of High Risk, Inherited Lysosomal and Peroxisomal Disorders by Reduced-Intensity Hematopoietic Cell Transplantation and Low-Dose Total Body Irradiation With Marrow Boosting by Volumetric-Modulated Arc Therapy (VMAT) | Lysosomal Storage Disease;Peroxisomal Disorder | Drug: Campath-1H;Drug: Clofarabine;Drug: Melphalan;Radiation: Total Body Irradiation with Marrow Boosting;Biological: Hematopoietic stem cell transplantation;Drug: Cyclosporine A;Drug: Mycophenolate mofetil | Masonic Cancer Center, University of Minnesota | NULL | Completed | N/A | 55 Years | All | 3 | N/A | United States |
| 2 | NCT01043640 (ClinicalTrials.gov) | December 2009 | 5/1/2010 | Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders | Allogeneic Hematopoietic Stem Cell Transplantation for Standard Risk Inherited Metabolic Disorders | Mucopolysaccharidosis;Hurler Syndrome;Hunter Syndrome;Maroteaux-Lamy Syndrome;Sly Syndrome;Alpha Mannosidosis;Fucosidosis;Aspartylglucosaminuria;Adrenoleukodystrophy (ALD);Krabbe Disease;Metachromatic Leukodystrophy (MLD);Sphingolipidoses;Peroxisomal Disorders | Drug: Campath-1H;Drug: Cyclophosphamide;Drug: Busulfan;Procedure: Allogeneic stem cell transplantation;Drug: Cyclosporine A;Drug: Mycophenolate Mofetil | Masonic Cancer Center, University of Minnesota | NULL | Completed | N/A | 21 Years | All | 46 | Phase 2 | United States |
| 3 | NCT00741338 (ClinicalTrials.gov) | September 2008 | 13/8/2008 | Immune Tolerance Study With Aldurazyme® (Laronidase) | A Trial of Antigen-specific Immune Tolerance Induction in Mucopolysaccharidosis I (MPS I) Patients Initiating Enzyme Replacement Therapy With Aldurazyme® (Laronidase) | Mucopolysaccharidosis I | Biological: Laronidase;Drug: Cyclosporine A (CsA);Drug: Azathioprine (Aza) | Genzyme, a Sanofi Company | BioMarin/Genzyme LLC | Completed | N/A | 5 Years | All | 7 | Phase 1;Phase 2 | Brazil;Russian Federation;Ukraine |
| 4 | NCT00383448 (ClinicalTrials.gov) | September 2006 | 29/9/2006 | HSCT for High Risk Inherited Inborn Errors | Treatment of High Risk, Inherited Lysosomal And Peroxisomal Disorders by Reduced Intensity Hematopoietic Stem Cell Transplantation | Adrenoleukodystrophy;Metachromatic Leukodystrophy;Globoid Cell Leukodystrophy;Tay Sachs Disease;Sandhoffs Disease;Wolman Disease;I-Cell Disease;Sanfilippo Syndrome;GM1 Gangliosidosis | Drug: Clofarabine;Procedure: Total body Irradiation;Drug: Melphalan;Biological: Hematopoietic Stem Cell Transplantation;Drug: Alemtuzumab;Drug: mycophenylate mofetil;Device: Cyclosporine A;Drug: Hydroxyurea | Masonic Cancer Center, University of Minnesota | NULL | Completed | N/A | 70 Years | All | 38 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01043640 (ClinicalTrials.gov) | December 2009 | 5/1/2010 | Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders | Allogeneic Hematopoietic Stem Cell Transplantation for Standard Risk Inherited Metabolic Disorders | Mucopolysaccharidosis;Hurler Syndrome;Hunter Syndrome;Maroteaux-Lamy Syndrome;Sly Syndrome;Alpha Mannosidosis;Fucosidosis;Aspartylglucosaminuria;Adrenoleukodystrophy (ALD);Krabbe Disease;Metachromatic Leukodystrophy (MLD);Sphingolipidoses;Peroxisomal Disorders | Drug: Campath-1H;Drug: Cyclophosphamide;Drug: Busulfan;Procedure: Allogeneic stem cell transplantation;Drug: Cyclosporine A;Drug: Mycophenolate Mofetil | Masonic Cancer Center, University of Minnesota | NULL | Completed | N/A | 21 Years | All | 46 | Phase 2 | United States |
| 2 | NCT00383448 (ClinicalTrials.gov) | September 2006 | 29/9/2006 | HSCT for High Risk Inherited Inborn Errors | Treatment of High Risk, Inherited Lysosomal And Peroxisomal Disorders by Reduced Intensity Hematopoietic Stem Cell Transplantation | Adrenoleukodystrophy;Metachromatic Leukodystrophy;Globoid Cell Leukodystrophy;Tay Sachs Disease;Sandhoffs Disease;Wolman Disease;I-Cell Disease;Sanfilippo Syndrome;GM1 Gangliosidosis | Drug: Clofarabine;Procedure: Total body Irradiation;Drug: Melphalan;Biological: Hematopoietic Stem Cell Transplantation;Drug: Alemtuzumab;Drug: mycophenylate mofetil;Device: Cyclosporine A;Drug: Hydroxyurea | Masonic Cancer Center, University of Minnesota | NULL | Completed | N/A | 70 Years | All | 38 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01033552 (ClinicalTrials.gov) | January 2010 | 14/12/2009 | Biochemical Correction of Severe EB by Allo HSCT and Off-the-shelf MSCs | MT2009-09: Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Stem Cell Transplantation and Off-the-shelf Mesenchymal Stem Cells | Epidermolysis Bullosa | Drug: Cyclophosphamide;Drug: Fludarabine;Drug: Anti-thymocyte globulin;Drug: Cyclosporine A;Drug: Mycophenolate mofetil;Procedure: Mesenchymal stem cell transplantation;Radiation: Total body irradiation;Procedure: Bone marrow or umbilical cord blood (UCG) stem cell transplantation | Masonic Cancer Center, University of Minnesota | NULL | Recruiting | N/A | 25 Years | All | 75 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00976300 (ClinicalTrials.gov) | January 2002 | 11/9/2009 | Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study | Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study | Systemic Lupus Erythematosus;Lupus Nephritis | Drug: Cyclosporine A;Drug: Cyclophosphamide | Institute of Rheumatology, Prague | Ministry of Health, Czech Republic;Charles University, Czech Republic;Palacky University;Department of Rheumatology, Hospital, Ceske Budejovice, Czech Republic;National Institute of Rheumatology, Piestany, Slovakia;Faculty Hospital St. Anna, Brno | Completed | 18 Years | 70 Years | Both | 40 | Phase 2 | Czech Republic |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR1900025087 | 2019-09-01 | 2019-08-10 | Cyclosporine A in the treatment of polymyositis /dermatomyositis associated interstitial pulmonary disease: a prospective, opened, multicenter, randomized, controlled clinical study | Cyclosporine A in the Treatment of Polymyositis /Dermatomyositis With Interstitial Lung Disease (CTP /DMILD): a Prospective, Opened, Randomized, Multicenter, Controlled Trial | Polymyositis/Dermatomyositis associated Interstitial Lung Disease | treatment group:CsA+glucocorticoid;control group:CTX+glucocorticoid; | Guangdong Provincial People's Hospital | NULL | Pending | Both | treatment group:75;control group:75; | Phase 4 | China | ||
| 2 | JPRN-UMIN000015469 | 2014/10/20 | 18/10/2014 | Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease | Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease - Comparison between tacrolimus and cyclosporine for the treatment of PM/DM-ILD | polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung disease | arm1: tacrolimus and predonisolon therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Taclorimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml. arm2: cyclosporine and predonisolone therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Cyclosporine is administered orally at initial dose of 3 mg/kg/day (twice daily before meal) and adjusted over time to maintain a whole-blood trough level of 100 - 150 ng/ml. | Second Division, Department of Internal medicine, Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | 18years-old | 75years-old | Male and Female | 50 | Not selected | Japan |
| 3 | JPRN-UMIN000001866 | 2009/04/01 | 10/04/2009 | Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis | Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis - Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis | Dermatomyositis or polymyositis with interstitial pneumonia | (1)The patients are initially treated with methylprednisolone (m-PSL) pulse (1000 mg daily for three days) followed by oral prednisolone (1mg/kg daily). (2)Continuous intravenous CyA (2 mg/kg daily for initial dose) is started following m-PSL pulse therapy, and the dosage will be adjusted to a level of 200-300ng/ml. | Department of Neurology and Rheumatology, Shinshu University School of Medicine | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 10 | Not selected | Japan |
| 4 | EUCTR2005-003956-37-GB (EUCTR) | 18/06/2008 | 20/03/2008 | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Juvenile Dermatomyositis at onset | Trade Name: treatment defined only by active substance Product Name: prednisone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methylprednisolone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methotrexate Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methotrexate Product Code: not available INN or Proposed INN: not availa | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 5 | EUCTR2005-003956-37-SE (EUCTR) | 23/02/2007 | 11/12/2006 | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Juvenile Dermatomyositis at onset | Trade Name: treatment defined only by active substance Product Name: Prednisone Product Code: Not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methylprednisolone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: not available Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Methotrexate Product Code: not available | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2005-003956-37-BE (EUCTR) | 13/11/2006 | 25/10/2006 | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM Trial | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM Trial | Juvenile Dermatomyositis at onset | Product Name: Prednisolone INN or Proposed INN: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone sodium succinate Product Name: Cyclosporine INN or Proposed INN: Cyclosporine A Product Name: Cyclosporine INN or Proposed INN: Cyclosporine A Product Name: Methotrexate INN or Proposed INN: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate | University Hospital Gent | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 7 | EUCTR2005-003956-37-DK (EUCTR) | 03/11/2006 | 15/09/2006 | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Juvenile Dermatomyositis at onset | Product Name: Prednisone Product Name: methylprednisolone Product Name: Cyclosporine Product Name: Cyclosporine Product Name: Cyclosporine Product Name: Metotrexate Product Name: Methotrexate | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | Belgium;Denmark;Netherlands;United Kingdom;Italy;Sweden | ||
| 8 | EUCTR2005-003956-37-NL (EUCTR) | 26/09/2006 | 01/06/2006 | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis:prednisone versus prednisone plus cyclosporine A versus prednisone plus mehotrexate | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis:prednisone versus prednisone plus cyclosporine A versus prednisone plus mehotrexate | Juvenile Dermatomyositis at onset | INN or Proposed INN: Prednisone INN or Proposed INN: Methylprednisolone INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 9 | EUCTR2005-003956-37-IT (EUCTR) | 02/05/2006 | 12/09/2006 | FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMIZED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE DERMATOMYOSITIS PREDNISONE VERSUS PREDNISONE PLUS CYCLOSPORINE A VERSUS PREDNISONE PLUS METHOTREXATE - ND | FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMIZED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE DERMATOMYOSITIS PREDNISONE VERSUS PREDNISONE PLUS CYCLOSPORINE A VERSUS PREDNISONE PLUS METHOTREXATE - ND | New Onset juvenile dermatomyositis MedDRA version: 6.1;Level: PT;Classification code 10012503 | INN or Proposed INN: Prednisone INN or Proposed INN: Methylprednisolone INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate | ISTITUTO GIANNINA GASLINI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 10 | NCT00323960 (ClinicalTrials.gov) | May 2006 | 9/5/2006 | Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis | Five-year Single-blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis: Prednisone Versus Prednisone Plus Cyclosporine a Versus Prednisone Plus Methotrexate | Juvenile Dermatomyositis | Drug: 3 MPDN pulse + PDN;Drug: 3 MPDN pulse + PDN + CSA;Drug: 3 MPDN pulse + PDN + MTX | Istituto Giannina Gaslini | Pediatric Rheumatology International Trials Organization | Recruiting | 1 Year | 18 Years | Both | 120 | Phase 3 | Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR-IPR-15005990 | 2015-03-23 | 2015-02-10 | Cyclosporine A in the Treatment of Interstitial Pneumonitis associated with Sjogren’s syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial | Cyclosporine A in the Treatment of Interstitial Pneumonitis associated with Sjogren’s syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial | Sjogren's syndrome | Treatment group:glucocorticoid+CsA;Control group:glucocorticoid+placebo; | Peking University People's Hospital | NULL | Pending | 18 | 75 | Both | Treatment group:120;Control group:120; | China | |
| 2 | NCT02370550 (ClinicalTrials.gov) | March 2015 | 18/2/2015 | Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome | Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial | Sjogren's Syndrome | Drug: Cyclosporin A;Drug: Prednisone;Drug: Placebo;Drug: Calcium carbonate D | Peking University People's Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 240 | Phase 4 | China |
| 3 | NCT01693393 (ClinicalTrials.gov) | March 2010 | 14/9/2012 | Low Dose Cyclosporin A in Primary Sjögren Syndrome | A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome | Sjögren´s Syndrome | Drug: Cyclosporine A | Charite University, Berlin, Germany | NULL | Completed | 18 Years | 75 Years | Both | 30 | Phase 2 | Germany |
| 4 | EUCTR2009-013976-38-DE (EUCTR) | 07/12/2009 | Phase II Trial of low-dose Sandimmun Optoral ® (Cyclosporine A) for the treatment of primary Sjögren's syndrome (pSS) - Cypress | Phase II Trial of low-dose Sandimmun Optoral ® (Cyclosporine A) for the treatment of primary Sjögren's syndrome (pSS) - Cypress | Primary Sjögren's Syndrome MedDRA version: 12.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome | Trade Name: Sandimmun Optoral Product Name: Sandimmun Optoral INN or Proposed INN: CICLOSPORIN Trade Name: Sandimmun Optoral Product Name: Sandimmun Optoral INN or Proposed INN: CICLOSPORIN Trade Name: Sandimmun Optoral Product Name: Sandimmun Optoral INN or Proposed INN: CICLOSPORIN | Charité Berlin, Department of rheumatology | Charité Berlin, department of rheumatology;Charité Berlin, department of rheumatology | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00001965 (ClinicalTrials.gov) | December 1999 | 18/1/2000 | Cyclosporine A to Treat Hypertrophic Cardiomyopathy (HCM) | Double Blind Placebo Controlled Study of Cyclosporin A in Patients With Left Ventricular Hypertrophy Caused by Sarcomeric Gene Mutations | Cardiomyopathy, Hypertrophic;Heart Hypertrophy | Drug: Cyclosporine A | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | N/A | N/A | Both | 32 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04328727 (ClinicalTrials.gov) | November 4, 2020 | 9/3/2020 | Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia | A Non-randomized, Open Label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin (r-ATG) and Cyclosporine A (CsA) in East-Asian Patients With Treatment Naive Severe Aplastic Anemia (REACTS) | Severe Aplastic Anemia (SAA) | Drug: eltrombopag;Drug: rabbit anti-thymocyte globulin (r-ATG);Drug: cyclosporine A (CsA) | Novartis Pharmaceuticals | NULL | Recruiting | 6 Years | N/A | All | 36 | Phase 2 | China;Japan |
| 2 | NCT04304820 (ClinicalTrials.gov) | May 7, 2020 | 10/3/2020 | Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA) | Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA) | Severe Aplastic Anemia | Drug: Eltrombopag;Drug: Cyclosporine;Drug: Horse-Anti-thymocyte-Globulin | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Recruiting | 3 Years | N/A | All | 39 | Phase 2 | United States |
| 3 | JPRN-UMIN000030453 | 2017/12/20 | 18/12/2017 | Efficacy of cyclosporine therapy in the treatment of non-severe aplastic anemia | Efficacy of cyclosporine therapy in the treatment of non-severe aplastic anemia - Aplastic anemia 01 study in West Japan Hematology Study Group (W-JHS AA01 study) | aplastic anemia | 1.Start CsA (Neoral or generic drugs emulsified in the same way as Neoral) at a dose of 3.5 mg/kg, bid (before breakfast and before dinner). 2.Measure the blood concentration of cyclosporine at 2 hours (C2) after taking the drug and determine the minimum dose of cyclosporine that produces C2 >600 ng/mL. Continue the dose of cyclosporine for 8 weeks. 3.Continue the treatment for further 44 weeks (a total of 52 weeks) when patients meet the response criteria of HI-E or HI-P at the end of the 8 week treatment. Treatments after the 52 weeks are not specified. When patients do not meet the IWG response criteria 2006 at the end of 8 weeks, the treatment is terminated and treatments after 9 weeks are not specified. | Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu | NULL | Recruiting | 16years-old | Not applicable | Male and Female | 33 | Not selected | Japan |
| 4 | EUCTR2016-002814-29-HU (EUCTR) | 07/09/2017 | 05/07/2017 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months. | SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR | First-line severe aplastic anaemia MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Hong Kong;Hungary;Mexico;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India | ||
| 5 | EUCTR2016-002814-29-NL (EUCTR) | 21/07/2017 | 29/03/2017 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia with follow-up up to 24-months. | SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR | First-line severe aplastic anaemia MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Hungary;Hong Kong;Mexico;Thailand;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT02998645 (ClinicalTrials.gov) | May 11, 2017 | 4/11/2016 | Eltrombopag Combined With Cyclosporine as First Line Therapy in Patients With Severe Acquired Aplastic Anemia | SOAR, Interventional Phase II Single-arm Study to Assess Efficacy and Safety of Eltrombopag Combined With Cyclosporine as First Line Therapy in Adult Patients With Severe Acquired Aplastic Anemia | Severe Aplastic Anemia | Drug: eltrombopag;Drug: Cyclosporine | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 54 | Phase 2 | Brazil;Hong Kong;India;Italy;Korea, Republic of;Mexico;Spain;Thailand;Turkey;Hungary;Netherlands |
| 7 | EUCTR2016-002814-29-ES (EUCTR) | 21/03/2017 | 16/12/2016 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months. | SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR | First-line severe aplastic anaemia MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Novartis Farmacéutica, S.A | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Qatar;Hong Kong;Spain;Turkey;Italy;India;France;Hungary;Mexico;Canada;Brazil;Netherlands;Korea, Republic of | |||
| 8 | NCT03413306 (ClinicalTrials.gov) | December 10, 2016 | 22/12/2017 | Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AA | A Phase II Multicenter Randomized Study of Eltrombopag Combined With Cyclosporine and hATG Versus hATG and CsA as First Line Treatment in Pediatric Patients With Severe Acquired Aplastic Anemia | Acquired Aplastic Anemia | Drug: Eltrombopag;Drug: IST (ATG + CsA) | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | NULL | Recruiting | 2 Years | 18 Years | All | 100 | Phase 3 | Russian Federation |
| 9 | EUCTR2014-000363-40-NL (EUCTR) | 07/01/2016 | 01/09/2015 | A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function. | A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE | Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia. MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE INN or Proposed INN: ELTROMBOPAG | European Society for Blood and Marrow Transplantation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Spain;Netherlands | ||
| 10 | EUCTR2014-000363-40-ES (EUCTR) | 26/10/2015 | 07/09/2015 | A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function. | A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE | Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia. MedDRA version: 18.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade INN or Proposed INN: ELTROMBOPAG | European Society for Blood and Marrow Transplantation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Spain | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT02462252 (ClinicalTrials.gov) | October 2015 | 25/5/2015 | Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome | A Phase IIA, Open-label Study Designed to Evaluate Efficacy and Safety of BL-8040 Followed by Anti-Thymocyte Globulin (hATG), Cyclosporine and Methylprednisolone in Adult Subjects With Aplastic Anemia (AA) or Hypoplastic Myelodysplastic Syndrome (MDS) | Aplastic Anemia;Hypoplastic Myelodysplastic Syndrome | Drug: BL-8040;Drug: horse anti-thymocyte globulin (hATG);Drug: Methylprednisolone;Drug: Cyclosporine | BioLineRx, Ltd. | NULL | Recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 12 | NCT02099747 (ClinicalTrials.gov) | July 2015 | 6/3/2014 | hATG+CsA vs hATG+CsA+Eltrombopag for SAA | A Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients. | Severe Aplastic Anemia | Drug: hATG;Drug: CsA;Drug: Eltrombopag | European Group for Blood and Marrow Transplantation | Novartis;Pfizer | Active, not recruiting | 15 Years | N/A | All | 202 | Phase 3 | France;Italy;Netherlands;Spain;Switzerland;United Kingdom;Germany |
| 13 | NCT02404025 (ClinicalTrials.gov) | May 12, 2015 | 26/2/2015 | Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) Subjects | A Non-randomized, Phase II Study of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A (ATG/CsA) in Subjects With Moderate or More Severe Aplastic Anemia Who Have Not Received Prior ATG/Anti-lymphocyte Globulin (ALG)-Based Immunosuppressive Therapy | Aplastic Anemia | Drug: Eltrombopag;Drug: Rabbit ATG;Drug: CsA | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 2 | Japan |
| 14 | NCT01760096 (ClinicalTrials.gov) | January 2013 | 1/1/2013 | 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) | 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) | 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 | Institute of Hematology & Blood Diseases Hospital | NULL | Active, not recruiting | 18 Years | N/A | Both | 50 | Phase 2 | China |
| 15 | NCT01642979 (ClinicalTrials.gov) | July 2012 | 14/7/2012 | Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria | Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria | 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 | Institute of Hematology & Blood Diseases Hospital | NULL | Active, not recruiting | 18 Years | N/A | Both | 120 | Phase 2 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT01995331 (ClinicalTrials.gov) | March 2012 | 21/11/2013 | Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia | Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia | Aplastic Anemia | Drug: cyclophosphamide,cyclosporine A | Xiaofan Zhu | NULL | Active, not recruiting | 1 Year | 18 Years | Both | 30 | Phase 4 | China |
| 17 | EUCTR2006-006577-25-SE (EUCTR) | 25/07/2007 | 11/06/2007 | A prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantation | A prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantation | Graft versus host disease prophylaxis in patients receiving stem cell transplantation due to: chronic myeloid leukemia (CML) in 1st or 2nd chronic phase, acute myeloid leukemia (AML) in complete remission, acute lymphoblastic leukemia (ALL) in complete remission, myelodysplastic syndrome, chronic lymphocytic leukemia, lymphoma, non-malignant disorders, severe aplastic anemia, hemoglobinopathies and metabolic disorders MedDRA version: 9.1;Level: LLT;Classification code 10018799;Term: GVHD | Trade Name: Rapamune Product Name: Rapamune INN or Proposed INN: SIROLIMUS Other descriptive name: Rapamycin Trade Name: Prograf Product Name: Prograf INN or Proposed INN: TACROLIMUS Other descriptive name: FK-506 Trade Name: Sandimmun Neoral Product Name: Sandimmun Neoral INN or Proposed INN: CICLOSPORIN Other descriptive name: CsA Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: MTX | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Finland;Sweden | |||
| 18 | NCT01231841 (ClinicalTrials.gov) | March 2005 | 29/10/2010 | Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic Anemia | Protocol for Prospective Phase II Study of Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin) and Cyclosporine (CsA) as a First Line Immunosuppressive (IS) Therapy for Severe Aplastic Anemia (sAA) | Aplastic Anemia | Drug: cyclosporine;Biological: anti-thymocyte globulin | The Cleveland Clinic | NULL | Completed | 12 Years | N/A | All | 20 | Phase 2 | United States |
| 19 | NCT00001964 (ClinicalTrials.gov) | December 2, 1999 | 18/1/2000 | Combination Therapy of Severe Aplastic Anemia | Treatment of Severe Aplastic Anemia With Combined Immunosuppression: Antithymocyte Globulin (ATG) and Cyclosporine A (CSA), and Mycophenolate Mofetil (MMF) | Severe Aplastic Anemia | Drug: Cyclosporine A;Drug: ATG;Drug: MMF | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 1 Year | 99 Years | All | 104 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01626092 (ClinicalTrials.gov) | July 11, 2012 | 20/6/2012 | Reduced-Intensity Hematopoietic Stem Cell Transplant for High Risk Lysosomal and Peroxisomal Disorders | Treatment of High Risk, Inherited Lysosomal and Peroxisomal Disorders by Reduced-Intensity Hematopoietic Cell Transplantation and Low-Dose Total Body Irradiation With Marrow Boosting by Volumetric-Modulated Arc Therapy (VMAT) | Lysosomal Storage Disease;Peroxisomal Disorder | Drug: Campath-1H;Drug: Clofarabine;Drug: Melphalan;Radiation: Total Body Irradiation with Marrow Boosting;Biological: Hematopoietic stem cell transplantation;Drug: Cyclosporine A;Drug: Mycophenolate mofetil | Masonic Cancer Center, University of Minnesota | NULL | Completed | N/A | 55 Years | All | 3 | N/A | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04470804 (ClinicalTrials.gov) | August 1, 2020 | 9/7/2020 | Sirolimus Treatment for Newly Diagnosed Primary Acquired PRCA | Sirolimus Treatment for Newly Diagnosed Primary Acquired Pure Red Cell Aplasia: a Single Center Prospective Study | Pure Red Cell Aplasia, Acquired | Drug: Sirolimus;Drug: Cyclosporine A | Bing Han | NULL | Not yet recruiting | 18 Years | 70 Years | All | 40 | Phase 4 | China |
| 2 | NCT01288131 (ClinicalTrials.gov) | January 2009 | 1/2/2011 | Study of Anti-r-HuEpo Associated Pure Red Cell Aplasia (PRCA) Treatment | Randomized Controlled Trial Study of Anti-r-HuEpo Associated PRCA Treated by Cyclosporine and Mycophenolate Mofetil (MMF) Compared With Cyclophosphamide and Prednisolone | Anti-r-HuEpo Associated PRCA Subjects | Drug: Cyclosporine combine with mycophenolate mofetil;Drug: Cyclophosphamide + pred | Chulalongkorn University | NULL | Terminated | 18 Years | 60 Years | Both | 8 | Phase 3 | Thailand |