Iron (DrugBank: Iron)
5 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 18 | 脊髄小脳変性症（多系統萎縮症を除く。） | 1 |
| 96 | クローン病 | 12 |
| 97 | 潰瘍性大腸炎 | 9 |
| 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 | 8 |
| 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 | NCT00224640 (ClinicalTrials.gov) | March 2005 | 16/9/2005 | Iron-Chelating Therapy and Friedreich Ataxia | Effect of Iron-Chelating Therapy in Friedreich Ataxia. Study Phase I/II | Friedreich Ataxia | Drug: Iron chelating intervention | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 13 Years | N/A | Both | 15 | Phase 1;Phase 2 | France |
| 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 | NCT02680756 (ClinicalTrials.gov) | January 2016 | 9/2/2016 | Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD | A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease | Anemia, Iron-Deficiency;Inflammatory Bowel Disease;Crohn's Disease | Drug: Ferric Maltol;Drug: Ferric Carboxy Maltose | Shield Therapeutics | NULL | Completed | 18 Years | N/A | All | 250 | Phase 3 | United States;Belgium;France;Germany;Hungary;Spain |
| 2 | ChiCTR-DDT-14004402 | 2014-03-28 | 2014-03-09 | The study of small bowel cleaning by using senna, 20% mannitol, simethicone and three days fasting | The study of small bowel cleaning by using senna, 20% mannitol, simethicone and three days fasting | Obscure gastrointestinal bleeding, iron deficiency anemia , Suspected Crohn’s disease, Suspected small bowel tumors, Surveillance of polyposis syndromes, malabsorption? Celiac disease, nonsteroidal a | Group A:20%Mannitol, 0.9% saline;Group B:20%Mannitol, 0.9% saline?simethicone;Group C:20%Mannitol, 0.9% saline?simethicone; | Sanming First Affiliated Hospital of Fujian Medical University | NULL | Completed | 10 | 85 | Both | Group A:60;Group B:60;Group C:60; | 4 (Phase 4 study) | China |
| 3 | NCT01823029 (ClinicalTrials.gov) | November 2012 | 25/3/2013 | Oxidative Stress and Inflammation Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia | Crohn's Disease | Drug: erythropoietin;Drug: enteral nutrition.;Drug: injection of iron | Jinling Hospital, China | Ministry of Health, China | Completed | 18 Years | 75 Years | Both | 387 | N/A | China | |
| 4 | EUCTR2010-023589-39-DE (EUCTR) | 10/04/2012 | 16/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 17.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 5 | NCT01991314 (ClinicalTrials.gov) | December 2011 | 18/11/2013 | Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate | Treatment of Iron Deficiency Anaemia in Adults and Adolescents With Inflammatory Bowel Disease Using Ferrous Sulphate: Tolerance and Effects on Haemoglobin, Mood, Quality of Life and Fatigue | Ulcerative Colitis;Crohn's Disease | Drug: Ferrous sulphate | Queen Mary University of London | NULL | Completed | 13 Years | 80 Years | All | 90 | Phase 4 | United Kingdom |
| 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 |
| 6 | EUCTR2010-023797-39-GB (EUCTR) | 12/08/2011 | 16/07/2011 | TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE | TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD. | Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Barts Health NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 4 | United Kingdom | |||
| 7 | EUCTR2010-023589-39-GB (EUCTR) | 02/08/2011 | 19/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Hungary;Austria;Germany;United Kingdom | |||
| 8 | NCT01352221 (ClinicalTrials.gov) | August 2011 | 10/5/2011 | Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2) | A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Crohn's Disease Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 2) | Iron Deficiency Anaemia;Inflammatory Bowel Disease;Crohn's Disease | Drug: ST10;Drug: Placebo oral capsule | Shield Therapeutics | NULL | Completed | 18 Years | N/A | All | 128 | Phase 3 | Austria;United Kingdom |
| 9 | EUCTR2010-023589-39-AT (EUCTR) | 22/06/2011 | 17/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 10 | NCT00810030 (ClinicalTrials.gov) | October 2008 | 16/12/2008 | FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR | Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Disease;Anemia;Iron Deficiency;Iron-Deficiency Anemia;Crohn's Disease;Ulcerative Colitis | Drug: Ferric carboxymaltose;Drug: Iron Sucrose | Vifor Inc. | Parexel;ClinStar | Completed | 18 Years | N/A | Both | 484 | Phase 3 | Austria;Russian Federation |
| 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 |
| 11 | NCT00152841 (ClinicalTrials.gov) | June 2002 | 7/9/2005 | Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn's Disease or Ulcerative Colitis | Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD) | Crohn's Disease;Ulcerative Colitis;Mild or Moderate Anaemia | Drug: Iron supplement 300-600 mg/day;Drug: Vitamin E 800IU | University Health Network, Toronto | Crohn's and Colitis Foundation | Terminated | 18 Years | N/A | Both | 30 | Phase 2 | Canada |
| 12 | EUCTR2010-023589-39-HU (EUCTR) | 26/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom |
| 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 | EUCTR2010-023588-16-DE (EUCTR) | 10/04/2012 | 05/05/2011 | A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC | Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 2 | NCT01991314 (ClinicalTrials.gov) | December 2011 | 18/11/2013 | Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate | Treatment of Iron Deficiency Anaemia in Adults and Adolescents With Inflammatory Bowel Disease Using Ferrous Sulphate: Tolerance and Effects on Haemoglobin, Mood, Quality of Life and Fatigue | Ulcerative Colitis;Crohn's Disease | Drug: Ferrous sulphate | Queen Mary University of London | NULL | Completed | 13 Years | 80 Years | All | 90 | Phase 4 | United Kingdom |
| 3 | EUCTR2010-023797-39-GB (EUCTR) | 12/08/2011 | 16/07/2011 | TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE | TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD. | Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Barts Health NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 4 | United Kingdom | |||
| 4 | EUCTR2010-023588-16-HU (EUCTR) | 11/08/2011 | 27/05/2011 | A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC | Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 5 | EUCTR2010-023588-16-GB (EUCTR) | 02/08/2011 | 11/05/2011 | A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC | Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 16.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 16.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Hungary;Austria;Germany;United Kingdom | |||
| 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 |
| 6 | NCT01340872 (ClinicalTrials.gov) | August 2011 | 19/4/2011 | Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1) | A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Ulcerative Colitis Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 1) | Iron Deficiency Anaemia;Inflammatory Bowel Disease;Ulcerative Colitis | Drug: ST10-021;Drug: Placebo Comparator | Shield Therapeutics | NULL | Completed | 18 Years | N/A | All | 128 | Phase 3 | Austria;United Kingdom |
| 7 | EUCTR2010-023588-16-AT (EUCTR) | 22/06/2011 | 16/05/2011 | A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC | Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 8 | NCT00810030 (ClinicalTrials.gov) | October 2008 | 16/12/2008 | FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR | Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Disease;Anemia;Iron Deficiency;Iron-Deficiency Anemia;Crohn's Disease;Ulcerative Colitis | Drug: Ferric carboxymaltose;Drug: Iron Sucrose | Vifor Inc. | Parexel;ClinStar | Completed | 18 Years | N/A | Both | 484 | Phase 3 | Austria;Russian Federation |
| 9 | NCT00152841 (ClinicalTrials.gov) | June 2002 | 7/9/2005 | Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn's Disease or Ulcerative Colitis | Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD) | Crohn's Disease;Ulcerative Colitis;Mild or Moderate Anaemia | Drug: Iron supplement 300-600 mg/day;Drug: Vitamin E 800IU | University Health Network, Toronto | Crohn's and Colitis Foundation | Terminated | 18 Years | N/A | Both | 30 | Phase 2 | Canada |
| 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 | NCT02979249 (ClinicalTrials.gov) | December 2016 | 29/11/2016 | Oral Iron for Erythropoietic Protoporphyrias | Effect of Oral Iron Therapy on Erythrocyte Protoporphyrin Levels in the Erythropoietic Protoporphyrias | Erythropoietic Protoporphyria;EPP;X-linked Protoporphyria;XLP | Drug: Oral Iron | Icahn School of Medicine at Mount Sinai | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | N/A | All | 16 | N/A | United States |
| 2 | 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 |
| 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 | EUCTR2011-006322-25-GB (EUCTR) | 08/10/2012 | 14/08/2012 | Extending the treatment of Iron Overload | A Phase 2, Open-label, Multicentre, Extension Safety and Tolerability Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using SSP-004184 (SPD602). | Patients with transfusional iron overload due to hereditary anemias such as sickle cell disease, beta-thalassemia and Diamond-Blackfan anemia; aquired anemias such as Myelodysplastic Syndrome and other forms of bone marrow failure. MedDRA version: 16.1;Level: LLT;Classification code 10065974;Term: Chronic iron overload;System Organ Class: 100000004861;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: SSP-004184AQ 50 mg Capsule Product Code: SSP-004184AQ 50 mg INN or Proposed INN: deferitazole Other descriptive name: (S)-4,5-dihydro-2[hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide Product Name: SSP-004184AQ 100 mg Capsule Product Code: SSP-004184AQ 100 mg INN or Proposed INN: deferitazole Other descriptive name: (S)-4,5-dihydro-2[hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide Product Name: SSP-004184AQ 200 mg Capsule Product Code: SSP-004184AQ 200 mg INN or Proposed INN: deferitazole Other descriptive name: (S)-4,5-dihydro-2[hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide Product Name: SSP-004184AQ 250 mg Capsule Product Code: SSP-004184AQ 250 mg INN or Proposed INN: deferitazole Other descriptive name: (S)-4,5-dihydro-2[hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide Product Name: SSP-004184AQ 375 mg Capsule Product Code: SSP-004184AQ 375 mg INN or Proposed INN: deferitazole Other descriptive name: (S)-4,5-dihydro-2[hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-m | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 2 | Egypt;United States;Canada;Thailand;Lebanon;Turkey;Italy;United Kingdom | ||
| 2 | EUCTR2011-006322-25-IT (EUCTR) | 20/08/2012 | 03/09/2012 | Extension to the treatment of iron overload with chelation therapy | A PHASE 3, OPEN-LABEL, MILTICENTRE, EXTENSION SAFETY AND TOLERABILITY STUDY FOR TRANSFUSIONALLY IRON OVERLOADED CHILDRE, ADOLISCENTS AND ADULTS USING FBS0701 (SSP-004184) - SPD602-301 (FBS0701 - CTP - 15) | ADULT PATIENTS SUFFERING FROM IRON OVERLOAD OF TRANSFUSION-DEPENDENT DOCUMENTED, IN WHICH THE FOLLOWING PRIMARY DIAGNOSIS: ANEMIA HEREDITARY (EG sickle cell anemia), thalassemia and Diamond-Blackfan anemia MedDRA version: 15.0;Level: LLT;Classification code 10065974;Term: Chronic iron overload;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: FBS0701 CAPSULE Product Code: FBS0701/SSP004184 INN or Proposed INN: iron chelating agents Product Name: FBS0701 CAPSULE Product Code: FBS0701/SSP004184 INN or Proposed INN: IRON CHELATING AGENTS Product Name: FBS0701 CAPSULE Product Code: FBS0701/SSP004184 INN or Proposed INN: IRON CHELATING AGENTS Product Name: FBS0701 CAPSULE Product Code: FBS0701/SSP004184 INN or Proposed INN: IRON CHELATING AGENTS Product Name: FBS0701 CAPSULE Product Code: FBS0701 INN or Proposed INN: IRON CHELATING AGENTS Product Name: FBS0701 CAPSULE Product Code: FBS0701/SSP004184 INN or Proposed INN: IRON CHELATING AGENTS | FERROKIN BIOSCIENCES INC. | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United States;United Kingdom;Italy | ||
| 3 | EUCTR2011-005675-16-IT (EUCTR) | 15/05/2012 | 02/08/2012 | Treatment of chronic iron overload with a chelation therapy (FBS0701) | A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two FBS0701 Doses in the Treatment of Chronic Iron Overload Requiring Chelation Therapy - FBS0701 in the treatment of chronic iron overload | Patients with transfusional iron overload, with the following primary diagnosis:hereditary anemia (such as sickle cell disease),ß-thalassemia and Diamond Blackfan anemia;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: FBS0701 CAPSULE Product Code: FBS0701 INN or Proposed INN: iron chelating agents Product Name: FBS0701 CAPSULE Product Code: FBS0701 INN or Proposed INN: Iron chelating agents Product Name: FBS0701 CAPSULE Product Code: FBS0701 INN or Proposed INN: Iron chelating agents Product Name: FBS0701 CAPSULE Product Code: FBS0701 INN or Proposed INN: iron chelating agents Product Name: FBS0701 CAPSULE Product Code: FBS0701 INN or Proposed INN: iron chelating agents | FERROKIN BIOSCIENCES INC. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Canada;Lebanon;Turkey;Italy | ||
| 4 | EUCTR2010-019645-25-IT (EUCTR) | 04/08/2010 | 15/07/2010 | A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, and Pharmacodynamics of FBS0701 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy. - ND | A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, and Pharmacodynamics of FBS0701 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy. - ND | Patients with transfusional iron overload due to hereditary anemias such as sickle cell disease, ß-thalassemia and Diamond-Blackfan anemia; acquired anemias such as Myelodysplastic Syndrome and other forms of bone marrow failure. | Product Name: FBS0701 Capsule Product Code: FBS0701 Product Name: FBS0701 Capsule Product Code: FBS0701 Product Name: FBS0701 Capsule Product Code: FBS0701 Product Name: FBS0701 Capsule Product Code: FBS0701 | FERROKIN BIOSCIENCES INC. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United Kingdom;Italy | ||
| 5 | EUCTR2010-019645-25-GB (EUCTR) | 19/07/2010 | 16/06/2010 | A 24 week trial to study the safety and tolerability of SSP-004184 in the treatment of patients with longterm iron overload who need iron chelation therapy, with the option of 72 weeks further dosing. | A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, and Pharmacodynamics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy, with a 72 Week Dosing Extension. - SPD602-201 | Patients with transfusional iron overload due to hereditary anemias such as sickle cell disease, ß-thalassemia and Diamond-Blackfan anemia; acquired anemias such as Myelodysplastic Syndrome and other forms of bone marrow failure. MedDRA version: 14.1;Level: LLT;Classification code 10065974;Term: Chronic iron overload;System Organ Class: 100000004861;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: SSP-004184 50 mg Capsule Product Code: SSP-004184 50 mg INN or Proposed INN: Not assigned Other descriptive name: (S)-4,5-dihydro-2-[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide Product Name: SSP-004184 100 mg Capsule Product Code: SSP-004184 100 mg INN or Proposed INN: Not assigned Other descriptive name: (S)-4,5-dihydro-2-[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide Product Name: SSP-004184 250 mg Capsule Product Code: SSP-004184 250 mg INN or Proposed INN: Not assigned Other descriptive name: (S)-4,5-dihydro-2-[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide Product Name: SSP-004184 375 mg Capsule Product Code: SSP-004184 375 mg INN or Proposed INN: Not assigned Other descriptive name: (S)-4,5-dihydro-2-[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazolecarboxylate magnesium hydroxide Product Name: SSP-004184 500 mg Capsule Product Code: SSP-004184 500 mg INN or Proposed INN: Not assigned Other descriptive name: (S)-4,5-dihydro-2-[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiazo | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Thailand;Turkey;Italy;United Kingdom | ||
| 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 |
| 6 | 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 | |||
| 7 | 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 |
| 8 | 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 |