Thymoglobuline®/Thymoglobulin® ( DrugBank: Thymoglobulin, Thymoglobuline )


1 disease
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3

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-DE
(EUCTR)
17/12/200929/09/2009Prospective Phase II Pilot study of Rabbit Antithymocyte globulin(ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients withAcquired Aplastic Anaemia and comparison with matched historicalpatients treated with horse ATG and Ciclosporin: a Study from theEuropean Blood and Marrow Transplant (EBMT) Severe AplasticAnaemia Working PartyProspective Phase II Pilot study of Rabbit Antithymocyte globulin(ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients withAcquired Aplastic Anaemia and comparison with matched historicalpatients treated with horse ATG and Ciclosporin: a Study from theEuropean Blood and Marrow Transplant (EBMT) Severe AplasticAnaemia Working Party Acquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemia
MedDRA version: 12.0;Level: LLT;Classification code 10002969;Term: Aplastic anemia
Trade Name: Thymoglobulin
Product Name: Thymoglobuline®/Thymoglobulin®
Product Code: anti-thymocyte globulin (rabbit)
EBMT (European Group for Blood and Marrow Transplantation)NULLNot RecruitingFemale: yes
Male: yes
35Phase 2France;Germany;United Kingdom
2EUCTR2007-000902-55-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
3EUCTR2007-000902-55-GB
(EUCTR)
19/09/200726/06/2007Prospective Phase II 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 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 Acquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemia
MedDRA version: 14.0;Level: LLT;Classification code 10002274;Term: Anemia aplastic;System Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: Thymoglobuline
Product Name: Thymoglobuline®/Thymoglobulin®
Product Code: anti-thymocyte globulin (rabbit)
INN or Proposed INN: GLYCINE
INN or Proposed INN: Sodium chloride
INN or Proposed INN: Mannitol
EBMT (European group for Blood and Marrow Transplantation)NULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Germany;United Kingdom