286. 遺伝性鉄芽球性貧血 Hereditary sideroblastic anemia Clinical trials / Disease details
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. | 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 | 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%. | 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 AG | NULL | Not 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): no | Italy;United Kingdom |