Ciclosporine ( DrugBank: Ciclosporine )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 60 | 再生不良性貧血 | 2 |
| 228 | 閉塞性細気管支炎 | 15 |
60. 再生不良性貧血
臨床試験数 : 245 / 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166
| 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-14005720 | 2015-01-01 | 2014-12-17 | A single center, Randomized controlled, opened clinical reserch for evaluating the effectiveness of recombinant human thrombopoietin combined with immunosuppressive therapy in the treatment of newly diagnosed acquired severe aplastic anemia | A single center, Randomized controlled, opened clinical reserch for evaluating the effectiveness of recombinant human thrombopoietin combined with immunosuppressive therapy in the treatment of newly diagnosed acquired severe aplastic anemia | severe aplastic anemia | TPO:rTPO;Ciclosporine:Ciclosporine; | Blood Diseases Hospital, Chinese Academy of Medical Sciences | NULL | Recruiting | 18 | 75 | Both | TPO:86;Ciclosporine:86; | I (Phase 1 study) | China |
| 2 | EUCTR2007-000902-55-FR (EUCTR) | 23/04/2008 | 04/10/2007 | Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin | Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin | Aquired aplastic anaemia and transfusion dependent non-severe aplastic anaemia MedDRA version: 9.1;Level: LLT;Classification code 10002274;Term: Anemia aplastic | Trade Name: Thymoglobuline Product Name: Thymoglobuline®/Thymoglobulin® Product Code: anti-thymocyte globulin (rabbit) Other descriptive name: GLYCINE Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: Mannitol Trade Name: Neoral Product Name: Ciclosporine INN or Proposed INN: Cyclosporin A Other descriptive name: Ciclosporine | EBMT (European group for Blood and Marrow Transplantation) | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | France;Germany;United Kingdom |
228. 閉塞性細気管支炎
臨床試験数 : 97 / 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 156
| 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 | EUCTR2011-004304-38-ES (EUCTR) | 19/09/2012 | 22/06/2012 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | A long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable | Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom | |||
| 2 | EUCTR2011-004304-38-GB (EUCTR) | 14/06/2012 | 09/12/2011 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | A long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable | Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom | ||
| 3 | EUCTR2011-004304-38-AT (EUCTR) | 13/03/2012 | 20/12/2011 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | A long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy | Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom | |||
| 4 | EUCTR2011-004304-38-BE (EUCTR) | 14/02/2012 | 15/12/2011 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | A long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable | Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | France;Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom | ||
| 5 | EUCTR2011-004304-38-DK (EUCTR) | 20/01/2012 | 19/12/2011 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | A long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable | Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | France;Canada;Belgium;Spain;Austria;Denmark;Germany;United Kingdom | ||
| 6 | EUCTR2011-004304-38-DE (EUCTR) | 06/01/2012 | 28/11/2011 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | A long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy | Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom | |||
| 7 | EUCTR2008-003800-73-BE (EUCTR) | 14/09/2010 | 08/01/2009 | A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patients | A phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients | Prevention of bronchiolitis obliterans syndrome in lung transplant MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom | ||
| 8 | EUCTR2008-003800-73-ES (EUCTR) | 22/07/2010 | 26/05/2010 | A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsEnsayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonar | A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsEnsayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonar | Prevention of bronchiolitis obliterans syndrome in lung transplantPrevención del sindrome de bronquiolitis obliterante en transplante pulmonar MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans | Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporina/ Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporina / Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Solucion de cloruro de sodio Sodium Chloride Solution Product Code: Solvente Cloruro de Sodio Sodium Chloride Solvent Other descriptive name: Cloruro de sodio Product Name: Solucion de Cloruro de Sodio Product Code: Solvente de Cloruro de Sodio Other descriptive name: Cloruro de Sodio | Pari Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 2 | Belgium;Spain;Denmark;Austria;Germany;United Kingdom | ||
| 9 | EUCTR2008-003800-73-DK (EUCTR) | 13/04/2010 | 18/08/2009 | A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients | A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients | Prevention of bronchiolitis obliterans syndrome in lung transplant MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans | Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride | Pari Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 2 | Spain;Belgium;Austria;Denmark;Germany;United Kingdom | ||
| 10 | EUCTR2008-003800-73-GB (EUCTR) | 27/08/2009 | 07/01/2009 | A phase II, multicentre, randomised, double-blind, placebo controlled, clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients | A phase II, multicentre, randomised, double-blind, placebo controlled, clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients | Prevention of bronchiolitis obliterans syndrome in lung transplant MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans | Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent | Pari Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Belgium;Denmark;Austria;Germany;United Kingdom | ||
| 11 | EUCTR2008-003800-73-DE (EUCTR) | 14/07/2009 | 29/12/2008 | A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patients | A phase II, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients | Prevention of bronchiolitis obliterans syndrome in lung transplant MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom | ||
| 12 | EUCTR2008-003800-73-AT (EUCTR) | 08/07/2009 | 11/05/2009 | A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patients | A phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients | Prevention of bronchiolitis obliterans syndrome in lung transplant MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, Ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom | ||
| 13 | EUCTR2008-003801-15-GB (EUCTR) | 26/02/2009 | 24/11/2010 | A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients | A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients | Bronchiolitis Obliterans Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans | Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride solvent Other descriptive name: Sodium Chloride | PARIPharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United Kingdom | ||
| 14 | EUCTR2004-001290-25-DE (EUCTR) | 17/08/2006 | 17/05/2006 | A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLungs | A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLungs | Heart-lung, bilateral lung and single lung transplant recipientsMain ICD Classification Codes:J84.1, J43-44, E84.0, Z94.2 | INN or Proposed INN: Everolimus INN or Proposed INN: Everolimus INN or Proposed INN: Enteric coated mycophenolate sodium INN or Proposed INN: Ciclosporine A INN or Proposed INN: Ciclosporine A INN or Proposed INN: Ciclosporine A | St Vincent’s Hospital, Sydney, Australia | NULL | Not Recruiting | Female: yes Male: yes | 320 | United Kingdom;Germany;Spain | |||
| 15 | EUCTR2008-003801-15-BE (EUCTR) | 08/01/2009 | A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients | A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients | Bronchiolitis Obliterans Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans | Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine, ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride solvent Other descriptive name: Sodium Chloride | PARIPharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Belgium;United Kingdom |