SODIUM CHLORIDE SOLUTION 0.9% ( DrugBank: Sodium chloride, Chloride )


3 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1
288自己免疫性後天性凝固因子欠乏症2
299嚢胞性線維症4

60. 再生不良性貧血


臨床試験数 : 235 薬物数 : 381 - (DrugBank : 83) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 160
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-000902-55-FR
(EUCTR)
23/04/200804/10/2007Prospective 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 CiclosporinProspective 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 2Germany;United Kingdom;France

288. 自己免疫性後天性凝固因子欠乏症


臨床試験数 : 205 薬物数 : 238 - (DrugBank : 31) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 26
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-003036-37-AT
(EUCTR)
27/10/201714/09/2017The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machineA double-blind, placebo-controlled pilot trial to investigate the administration of von Willebrand factor concentrate (Willfact®, LFB France) in adult patients during extracorporeal membrane oxygenation - Von Willebrand factor concentrate during ECMO support Von Willebrand Disease (VWD)
MedDRA version: 20.0;Level: PT;Classification code 10069495;Term: Acquired Von Willebrand's disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Willfact
Product Name: Willfact
INN or Proposed INN: von Willebrand Faktor
Other descriptive name: VON WILLEBRAND FACTOR
Trade Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung
Product Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung
INN or Proposed INN: Natriumchlorid 0,9 %
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Trade Name: Willfact
Product Name: Willfact
INN or Proposed INN: von Willebrand Faktor
Other descriptive name: VON WILLEBRAND FACTOR
Trade Name: Willfact
Product Name: Willfact
INN or Proposed INN: von Willebrand Faktor
Other descriptive name: VON WILLEBRAND FACTOR
Tirol Kliniken GmbHNULLNot RecruitingFemale: yes
Male: yes
68Phase 2Austria
2EUCTR2016-000789-53-AT
(EUCTR)
09/03/201717/10/2016The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machineA pilot trial to investigate the administration of von Willebrand factor concentrate (Willfact®, LFB France) in adult patients during extracorporeal membrane oxygenation - Willfact during ECMO Von Willebrand Disease (VWD)
MedDRA version: 19.1;Level: PT;Classification code 10069495;Term: Acquired Von Willebrand's disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Willfact
Product Name: Willfact
INN or Proposed INN: von Willebrand Faktor
Other descriptive name: VON WILLEBRAND FACTOR
Trade Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung
Product Name: Physiologische Kochsalzlösung Fresenius - Infusionslösung
INN or Proposed INN: Natriumchlorid 0,9 %
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Trade Name: Willfact
Product Name: Willfact
INN or Proposed INN: von Willebrand Faktor
Other descriptive name: VON WILLEBRAND FACTOR
Trade Name: Willfact
Product Name: Willfact
INN or Proposed INN: von Willebrand Faktor
Other descriptive name: VON WILLEBRAND FACTOR
Medizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische IntensivmedizinNULLNot RecruitingFemale: yes
Male: yes
Phase 2Austria

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-004143-39-IT
(EUCTR)
19/12/201820/09/2018Saline hypertonic in preschoolers and lung structure as measured by computed tomography.A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Hypertonic saline
INN or Proposed INN: SODIUM CHLORIDE 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Erasmus MCNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy
2EUCTR2015-004143-39-DK
(EUCTR)
14/02/201725/10/2016Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure asmeasured by computedtomography (CT). SHIP-CT study.A Phase 3 randomised, double-blind, controlled trial of inhaled 7%hypertonic saline versus0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6years of age inparallel with the North American SHIP clinical trial - Ship-CT study Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Hypertonic saline
INN or Proposed INN: sodium chloride 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline 0.9%
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Erasmus MCNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;Belgium;Australia;Denmark;Netherlands;Italy
3EUCTR2015-004143-39-BE
(EUCTR)
30/11/201613/10/2016Saline hypertonic in preschoolers and lung structure as measured by computed tomography.A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Hypertonic saline
INN or Proposed INN: SODIUM CHLORIDE 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Spain;Belgium;Denmark;Australia;Netherlands
4EUCTR2015-004143-39-NL
(EUCTR)
09/08/201621/12/2015Saline hypertonic in preschoolers and lung structure as measured by computed tomography.A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Hypertonic saline
INN or Proposed INN: SODIUM CHLORIDE 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Erasmus MCNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy