EXJADE ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
254ポルフィリン症1
284ダイアモンド・ブラックファン貧血3
286遺伝性鉄芽球性貧血4

254. ポルフィリン症


臨床試験数 : 72 薬物数 : 53 - (DrugBank : 16) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 35
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01284946
(ClinicalTrials.gov)
January 201126/1/2011Safety and Efficacy of Oral Deferasirox in Patients With Porphyria Cutanea TardaA Phase II, Open Label Clinical Trial Exploring the Safety and the Efficacy of Oral Deferasirox in Patients Newly Diagnosed With Porphyria Cutanea Tarda (PCT) and Non-transfusion Iron OverloadPorphyria Cutanea TardaDrug: ExjadeAssistance Publique - Hôpitaux de ParisAssociation pour l'Etude des Fonctions Digestives (AEFD)Recruiting18 YearsN/ABoth45Phase 2France

284. ダイアモンド・ブラックファン貧血


臨床試験数 : 36 薬物数 : 95 - (DrugBank : 34) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-000766-20-GB
(EUCTR)
17/07/200813/12/2007A multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions - CORDELIAA multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions - CORDELIA Beta-thalassemia major (TM) or Diamond Blackfan anemia (DBA) or myelodysplastic syndromes (MDS) (low and INT-1 risk as per the IPSS for MDS) or sideroblastic anemia and myocardial iron overload as indicated by a T2* =6 but not greater than 20 ms, with no symptoms of cardiac dysfunction, and an MRI measured LVEF =56%.Trade Name: Exjade
Product Name: EXJADE
Product Code: ICL670
INN or Proposed INN: deferasirox
Other descriptive name: EXJADE
Trade Name: Exjade
Product Name: EXJADE
Product Code: ICL670
INN or Proposed INN: deferasirox
Other descriptive name: EXJADE
Trade Name: Exjade
Product Name: EXJADE
Product Code: ICL670
INN or Proposed INN: deferasirox
Other descriptive name: EXJADE
Trade Name: Desferal
Product Name: Desferal
Product Code: DFO
INN or Proposed INN: deferoxamine
Trade Name: Desferal
Product Name: Desferal
Product Code: DFO
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
192 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly;United Kingdom
2NCT00673608
(ClinicalTrials.gov)
November 20075/5/2008Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron OverloadA Study of Magnetic Resonance Imaging Assessment of Cardiac and Liver Iron Load in Patients With Haemoglobinopathies, Myelodysplastic Syndromes (MDS) or Other Anaemias Treated With Exjade® (Deferasirox) (The MILE Study)Hemoglobinopathies;Myelodysplastic Syndromes;Other Inherited or Acquired Anaemia;MPD Syndrome;Diamond-Blackfan Anemia;Other Rare Anaemias;Transfusional Iron OverloadDrug: deferasiroxNovartisNULLCompleted18 YearsN/AAll118Phase 4Australia
3NCT00235391
(ClinicalTrials.gov)
October 20056/10/2005Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron OverloadA Study to Provide Expanded Access of (Exjade®) Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload From Blood Transfusions Who Cannot Adequately be Treated With Other Locally Approved Iron ChelatorsThalassemia;Sickle Cell Disease;Diamond Blackfan Anemia;MyelofibrosisDrug: DeferasiroxNovartis PharmaceuticalsNULLCompleted2 YearsN/AAll1683Phase 3United States;Belgium;Canada;Germany;Greece;Italy;Netherlands;Spain;Taiwan;Thailand;Turkey;United Kingdom;Australia

286. 遺伝性鉄芽球性貧血


臨床試験数 : 7 薬物数 : 20 - (DrugBank : 10) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 43
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-021062-29-GR
(EUCTR)
12/04/201102/02/2011Phase II, open-label, single-arm, multicenter study to evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed by deferasirox monotherapy in patients with severe cardiac iron overload due to chronic blood transfusion (HYPERION) - HYPERIONPhase II, open-label, single-arm, multicenter study to evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed by deferasirox monotherapy in patients with severe cardiac iron overload due to chronic blood transfusion (HYPERION) - HYPERION transfusion-dependent patients with TM, DBA or congenital sideroblastic anemia with severe cardiac iron overload
MedDRA version: 13.1;Level: LLT;Classification code 10065974;Term: Chronic iron overload;System Organ Class: 10027433 - Metabolism and nutrition disorders
Trade Name: Exjade
Product Name: Exjade
Product Code: ICL670
INN or Proposed INN: DEFERASIROX
Other descriptive name: Exjade
Trade Name: Exjade
Product Name: Exjade
Product Code: ICL670
INN or Proposed INN: DEFERASIROX
Other descriptive name: Exjade
Trade Name: Exjade
Product Name: Exjade
Product Code: ICL670
INN or Proposed INN: DEFERASIROX
Other descriptive name: Exjade
Trade Name: Desferal
Product Name: deferoxamine
Product Code: DFO
INN or Proposed INN: DEFEROXAMINE MESILATE
Trade Name: DESFERAL
Product Name: deferoxamine
Product Code: DFO
INN or Proposed INN: DEFEROXAMINE MESILATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Greece;Italy;United Kingdom
2EUCTR2010-021062-29-IT
(EUCTR)
30/12/201029/11/2010Phase II, open-label, single-arm, multicenter study to evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed by deferasirox monotherapy in patients with severe cardiac iron overload due to chronic blood transfusion (HYPERION) - HYPERIONPhase II, open-label, single-arm, multicenter study to evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed by deferasirox monotherapy in patients with severe cardiac iron overload due to chronic blood transfusion (HYPERION) - HYPERION Transfusion-dependent patients with TM, DBA or congenital sideroblastic anemia with severe cardiac iron overload
MedDRA version: 9.1;Level: LLT;Classification code 10043392
Trade Name: EXJADE
INN or Proposed INN: DEFERASIROX
Trade Name: EXJADE
INN or Proposed INN: DEFERASIROX
Trade Name: EXJADE
INN or Proposed INN: DEFERASIROX
Trade Name: DESFERAL
INN or Proposed INN: Deferoxamine
Trade Name: DESFERAL
INN or Proposed INN: Deferoxamine
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
45Phase 2Greece;United Kingdom;Italy
3EUCTR2010-021062-29-GB
(EUCTR)
21/12/201020/10/2010Phase II, open-label, single-arm, multicenter study to evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed by deferasirox monotherapy in patients with severe cardiac iron overload due to chronic blood transfusion (HYPERION) - HYPERIONPhase II, open-label, single-arm, multicenter study to evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed by deferasirox monotherapy in patients with severe cardiac iron overload due to chronic blood transfusion (HYPERION) - HYPERION transfusion-dependent patients with TM, DBA or congenital sideroblastic anemia with severe cardiac iron overload
MedDRA version: 14.1;Level: LLT;Classification code 10065974;Term: Chronic iron overload;System Organ Class: 10027433 - Metabolism and nutrition disorders
Trade Name: Exjade
Product Name: Exjade
Product Code: ICL670
INN or Proposed INN: DEFERASIROX
Other descriptive name: Exjade
Trade Name: Exjade
Product Name: Exjade
Product Code: ICL670
INN or Proposed INN: DEFERASIROX
Other descriptive name: Exjade
Trade Name: Exjade
Product Name: Exjade
Product Code: ICL670
INN or Proposed INN: DEFERASIROX
Other descriptive name: Exjade
Product Name: deferoxamine
Product Code: DFO
INN or Proposed INN: DEFEROXAMINE MESILATE
Product Name: deferoxamine
Product Code: DFO
INN or Proposed INN: DEFEROXAMINE MESILATE
Trade Name: Exjade
Product Name: Exjade
Product Code: ICL670
INN or Proposed INN: deferasirox
INN or Proposed INN: deferasirox
INN or Proposed INN: deferasirox
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Greece;Italy;United Kingdom
4EUCTR2007-000766-20-GB
(EUCTR)
17/07/200813/12/2007A multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions - CORDELIAA multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions - CORDELIA Beta-thalassemia major (TM) or Diamond Blackfan anemia (DBA) or myelodysplastic syndromes (MDS) (low and INT-1 risk as per the IPSS for MDS) or sideroblastic anemia and myocardial iron overload as indicated by a T2* =6 but not greater than 20 ms, with no symptoms of cardiac dysfunction, and an MRI measured LVEF =56%.Trade Name: Exjade
Product Name: EXJADE
Product Code: ICL670
INN or Proposed INN: deferasirox
Other descriptive name: EXJADE
Trade Name: Exjade
Product Name: EXJADE
Product Code: ICL670
INN or Proposed INN: deferasirox
Other descriptive name: EXJADE
Trade Name: Exjade
Product Name: EXJADE
Product Code: ICL670
INN or Proposed INN: deferasirox
Other descriptive name: EXJADE
Trade Name: Desferal
Product Name: Desferal
Product Code: DFO
INN or Proposed INN: deferoxamine
Trade Name: Desferal
Product Name: Desferal
Product Code: DFO
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
192 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly;United Kingdom