Deferasirox (DrugBank: Deferasirox)
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 | 2 |
| 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 |
| 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 | NCT01284946 (ClinicalTrials.gov) | January 2011 | 26/1/2011 | Safety and Efficacy of Oral Deferasirox in Patients With Porphyria Cutanea Tarda | A 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 Overload | Porphyria Cutanea Tarda | Drug: Exjade | Assistance Publique - Hôpitaux de Paris | Association pour l'Etude des Fonctions Digestives (AEFD) | Recruiting | 18 Years | N/A | Both | 45 | Phase 2 | France |
| 2 | NCT00599326 (ClinicalTrials.gov) | January 2008 | 10/1/2008 | Pilot Trial of Deferasirox in the Treatment of Porphyria Cutanea Tarda | Pilot Trial of Deferasirox in the Treatment of Porphyria Cutanea Tarda | Porphyria Cutanea Tarda | Drug: Deferasirox | University of Texas Southwestern Medical Center | Novartis Pharmaceuticals | Completed | 18 Years | N/A | All | 10 | Phase 3 | United States |
| 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 | EUCTR2007-000766-20-GB (EUCTR) | 17/07/2008 | 13/12/2007 | A multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions - CORDELIA | A 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%. | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 2 | Italy;United Kingdom | |||
| 2 | NCT00673608 (ClinicalTrials.gov) | November 2007 | 5/5/2008 | Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload | A 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 Overload | Drug: deferasirox | Novartis | NULL | Completed | 18 Years | N/A | All | 118 | Phase 4 | Australia |
| 3 | NCT00235391 (ClinicalTrials.gov) | October 2005 | 6/10/2005 | Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload | A 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 Chelators | Thalassemia;Sickle Cell Disease;Diamond Blackfan Anemia;Myelofibrosis | Drug: Deferasirox | Novartis Pharmaceuticals | NULL | Completed | 2 Years | N/A | All | 1683 | Phase 3 | United States;Belgium;Canada;Germany;Greece;Italy;Netherlands;Spain;Taiwan;Thailand;Turkey;United Kingdom;Australia |
| 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 | EUCTR2010-021062-29-GR (EUCTR) | 12/04/2011 | 02/02/2011 | Phase 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 | Phase 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Greece;Italy;United Kingdom | ||
| 2 | EUCTR2010-021062-29-IT (EUCTR) | 30/12/2010 | 29/11/2010 | Phase 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 | Phase 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Greece;United Kingdom;Italy | ||
| 3 | EUCTR2010-021062-29-GB (EUCTR) | 21/12/2010 | 20/10/2010 | Phase 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 | Phase 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Greece;Italy;United Kingdom | ||
| 4 | EUCTR2007-000766-20-GB (EUCTR) | 17/07/2008 | 13/12/2007 | A multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions - CORDELIA | A 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%. | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 2 | Italy;United Kingdom |