CICLOSPORINA ( DrugBank: Ciclosporina )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス1
60再生不良性貧血1
97潰瘍性大腸炎1
228閉塞性細気管支炎14

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-017273-38-ES
(EUCTR)
26/10/201027/07/2010Estudio fase III, multicéntrico, aleatorizado, abierto de grupos paralelos para comparar la eficacia y seguridad de la pauta Prednisona-Ac Micofenólico-Ciclosporina a Prednisona-Ac Micofenólico en el tratamiento de las nefropatias lúpicas tipo III-IV-VEstudio fase III, multicéntrico, aleatorizado, abierto de grupos paralelos para comparar la eficacia y seguridad de la pauta Prednisona-Ac Micofenólico-Ciclosporina a Prednisona-Ac Micofenólico en el tratamiento de las nefropatias lúpicas tipo III-IV-V Nefritis lúpico tipo III,IV y V.
MedDRA version: 9;Level: LLT;Classification code 10029142;Term: Nephritis systemic lupus erythematosus
Product Name: Ciclosporina
Product Code: Csa
INN or Proposed INN: CICLOSPORINA
Other descriptive name: CICLOSPORIN
INN or Proposed INN: PREDNISONA
Other descriptive name: PREDNISONE
Product Name: Acido Micofenolico
Product Code: ACM
INN or Proposed INN: MICOFENOLICO ACIDO
Other descriptive name: MYCOPHENOLIC ACID
Manuel Praga TerenteNULLNot RecruitingFemale: yes
Male: yes
38Spain

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002814-29-IT
(EUCTR)
14/06/201924/05/2021SOAR, 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 anemiaSOAR, 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: SANDIMMUN NEORAL - 10 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral ]
INN or Proposed INN: 00070500
Other descriptive name: CICLOSPORINA
Trade Name: SANDIMMUN NEORAL - 25 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Other descriptive name: CICLOSPORINA
Trade Name: SANDIMMUN NEORAL - 50 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Trade Name: SANDIMMUN NEORAL - 100 MG CAPSULE MOLLI 30 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Trade Name: REVOLADE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU) 28 COMPRESSE
Product Name: Eltrombopag
Product Code: [ETB115]
INN or Proposed INN: 00319301
Other descriptive name: Eltrombopag
Trade Name: REVOLADE - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Hungary;Hong Kong;Mexico;Spain;Thailand;Brazil;Korea, Democratic People's Republic of;Turkey;Netherlands;Italy;India

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-005299-42-ES
(EUCTR)
19/05/200803/03/2008Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIFEstudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF Brote grave de colitis ulcerosa (Severe flare of ulcerative colitis)Trade Name: Sandimmum
Product Name: ciclosporina
Trade Name: Remicade
Product Name: infliximab
GETECCU (Grupo Español para el estudio de la enfermedad de Crohn y la colitis ulcerosa)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Finland;Belgium;France;Spain

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-004304-38-ES
(EUCTR)
19/09/201222/06/2012An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
2EUCTR2011-004304-38-GB
(EUCTR)
14/06/201209/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
3EUCTR2011-004304-38-AT
(EUCTR)
13/03/201220/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
4EUCTR2011-004304-38-BE
(EUCTR)
14/02/201215/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
5EUCTR2011-004304-38-DK
(EUCTR)
20/01/201219/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Belgium;Spain;Austria;Denmark;Germany;United Kingdom
6EUCTR2011-004304-38-DE
(EUCTR)
06/01/201228/11/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
40France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
7EUCTR2008-003800-73-BE
(EUCTR)
14/09/201008/01/2009A 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 patientsA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
8EUCTR2008-003800-73-ES
(EUCTR)
22/07/201026/05/2010A 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 pulmonarA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
134Phase 2Belgium;Spain;Denmark;Austria;Germany;United Kingdom
9EUCTR2008-003800-73-DK
(EUCTR)
13/04/201018/08/2009A 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) patientsA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
134Phase 2Spain;Belgium;Austria;Denmark;Germany;United Kingdom
10EUCTR2008-003800-73-GB
(EUCTR)
27/08/200907/01/2009A 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) patientsA 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 GmbHNULLNot 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): noSpain;Belgium;Denmark;Austria;Germany;United Kingdom
11EUCTR2008-003800-73-DE
(EUCTR)
14/07/200929/12/2008A 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 patientsA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
12EUCTR2008-003800-73-AT
(EUCTR)
08/07/200911/05/2009A 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 patientsA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
13EUCTR2008-003801-15-GB
(EUCTR)
26/02/200924/11/2010A 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) patientsA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 2United Kingdom
14EUCTR2008-003801-15-BE
(EUCTR)
08/01/2009A 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) patientsA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Belgium;United Kingdom