Iron ( DrugBank: Iron )


6 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10
238ビタミンD抵抗性くる病/骨軟化症1
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

18. 脊髄小脳変性症(多系統萎縮症を除く。)


臨床試験数 : 71 薬物数 : 101 - (DrugBank : 30) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 65
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00224640
(ClinicalTrials.gov)
March 200516/9/2005Iron-Chelating Therapy and Friedreich AtaxiaEffect of Iron-Chelating Therapy in Friedreich Ataxia. Study Phase I/IIFriedreich AtaxiaDrug: Iron chelating interventionAssistance Publique - Hôpitaux de ParisNULLCompleted13 YearsN/ABoth15Phase 1/Phase 2France

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,417 - (DrugBank : 267) / 標的遺伝子数 : 168 - 標的パスウェイ数 : 214
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02680756
(ClinicalTrials.gov)
January 20169/2/2016Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBDA 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 DiseaseAnemia, Iron-Deficiency;Inflammatory Bowel Disease;Crohn's DiseaseDrug: Ferric Maltol;Drug: Ferric Carboxy MaltoseShield TherapeuticsNULLCompleted18 YearsN/AAll250Phase 3United States;Belgium;France;Germany;Hungary;Spain
2ChiCTR-DDT-14004402
2014-03-282014-03-09The study of small bowel cleaning by using senna, 20% mannitol, simethicone and three days fastingThe 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 aGroup 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 UniversityNULLCompleted1085BothGroup A:60;Group B:60;Group C:60;4 (Phase 4 study)China
3NCT01823029
(ClinicalTrials.gov)
November 201225/3/2013Oxidative Stress and Inflammation Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency AnemiaCrohn's DiseaseDrug: erythropoietin;Drug: enteral nutrition.;Drug: injection of ironJinling Hospital, ChinaMinistry of Health, ChinaCompleted18 Years75 YearsBoth387N/AChina
4EUCTR2010-023589-39-DE
(EUCTR)
10/04/201216/05/2011A 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) AGNULLNot RecruitingFemale: yes
Male: yes
60Hungary;Austria;Germany;United Kingdom
5NCT01991314
(ClinicalTrials.gov)
December 201118/11/2013Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous SulphateTreatment 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 FatigueUlcerative Colitis;Crohn's DiseaseDrug: Ferrous sulphateQueen Mary University of LondonNULLCompleted13 Years80 YearsAll90Phase 4United Kingdom
6EUCTR2010-023797-39-GB
(EUCTR)
12/08/201116/07/2011TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASETREATMENT 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
Trade Name: Iron sulphate 200mg coated tablets
Product Name: Ferrous sulphate
Product Code: Ferrous sulphate
INN or Proposed INN: Iron sulphate
Trade Name: CosmoFer
Product Name: CosmoFer 50mg/ml solution for infusion or injection
INN or Proposed INN: iron(III)- hydroxide dextran complex
Barts Health NHS TrustNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
7EUCTR2010-023589-39-GB
(EUCTR)
02/08/201119/05/2011A 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) AGNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Austria;Germany;United Kingdom
8NCT01352221
(ClinicalTrials.gov)
August 201110/5/2011Safety 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 DiseaseDrug: ST10;Drug: Placebo oral capsuleShield TherapeuticsNULLCompleted18 YearsN/AAll128Phase 3Austria;United Kingdom
9EUCTR2010-023589-39-AT
(EUCTR)
22/06/201117/05/2011A 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) AGNULLNot RecruitingFemale: yes
Male: yes
60Hungary;Austria;Germany;United Kingdom
10NCT00810030
(ClinicalTrials.gov)
October 200816/12/2008FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-CORSelect 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 DiseaseInflammatory Bowel Disease;Anemia;Iron Deficiency;Iron-Deficiency Anemia;Crohn's Disease;Ulcerative ColitisDrug: Ferric carboxymaltose;Drug: Iron SucroseVifor Inc.Parexel;ClinStarCompleted18 YearsN/ABoth484Phase 3Austria;Russian Federation
11NCT00152841
(ClinicalTrials.gov)
June 20027/9/2005Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn's Disease or Ulcerative ColitisEffect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD)Crohn's Disease;Ulcerative Colitis;Mild or Moderate AnaemiaDrug: Iron supplement 300-600 mg/day;Drug: Vitamin E 800IUUniversity Health Network, TorontoCrohn's and Colitis FoundationTerminated18 YearsN/ABoth30Phase 2Canada
12EUCTR2010-023589-39-HU
(EUCTR)
26/05/2011A 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) AGNULLNot RecruitingFemale: yes
Male: yes
60Hungary;Austria;Germany;United Kingdom

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,503 - (DrugBank : 259) / 標的遺伝子数 : 143 - 標的パスウェイ数 : 201
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05225545
(ClinicalTrials.gov)
November 4, 20199/10/2020Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative ColitisRandomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative ColitisAnemia, Iron Deficiency;Ulcerative ColitisDrug: Sucrosomial Iron;Drug: Oral IronAmerican University of Beirut Medical CenterPharma MRecruiting18 YearsN/AAll30Phase 3Lebanon
2EUCTR2010-023588-16-DE
(EUCTR)
10/04/201205/05/2011A 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) AGNULLNot RecruitingFemale: yes
Male: yes
60Hungary;Austria;Germany;United Kingdom
3NCT01991314
(ClinicalTrials.gov)
December 201118/11/2013Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous SulphateTreatment 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 FatigueUlcerative Colitis;Crohn's DiseaseDrug: Ferrous sulphateQueen Mary University of LondonNULLCompleted13 Years80 YearsAll90Phase 4United Kingdom
4EUCTR2010-023797-39-GB
(EUCTR)
12/08/201116/07/2011TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASETREATMENT 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
Trade Name: Iron sulphate 200mg coated tablets
Product Name: Ferrous sulphate
Product Code: Ferrous sulphate
INN or Proposed INN: Iron sulphate
Trade Name: CosmoFer
Product Name: CosmoFer 50mg/ml solution for infusion or injection
INN or Proposed INN: iron(III)- hydroxide dextran complex
Barts Health NHS TrustNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
5EUCTR2010-023588-16-HU
(EUCTR)
11/08/201127/05/2011A 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) AGNULLNot RecruitingFemale: yes
Male: yes
60Hungary;Austria;Germany;United Kingdom
6EUCTR2010-023588-16-GB
(EUCTR)
02/08/201111/05/2011A 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]
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) AGNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Austria;Germany;United Kingdom
7NCT01340872
(ClinicalTrials.gov)
August 201119/4/2011Safety 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 ColitisDrug: ST10-021;Drug: Placebo ComparatorShield TherapeuticsNULLCompleted18 YearsN/AAll128Phase 3Austria;United Kingdom
8EUCTR2010-023588-16-AT
(EUCTR)
22/06/201116/05/2011A 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) AGNULLNot RecruitingFemale: yes
Male: yes
60Hungary;Austria;Germany;United Kingdom
9NCT00810030
(ClinicalTrials.gov)
October 200816/12/2008FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-CORSelect 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 DiseaseInflammatory Bowel Disease;Anemia;Iron Deficiency;Iron-Deficiency Anemia;Crohn's Disease;Ulcerative ColitisDrug: Ferric carboxymaltose;Drug: Iron SucroseVifor Inc.Parexel;ClinStarCompleted18 YearsN/ABoth484Phase 3Austria;Russian Federation
10NCT00152841
(ClinicalTrials.gov)
June 20027/9/2005Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn's Disease or Ulcerative ColitisEffect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD)Crohn's Disease;Ulcerative Colitis;Mild or Moderate AnaemiaDrug: Iron supplement 300-600 mg/day;Drug: Vitamin E 800IUUniversity Health Network, TorontoCrohn's and Colitis FoundationTerminated18 YearsN/ABoth30Phase 2Canada

238. ビタミンD抵抗性くる病/骨軟化症


臨床試験数 : 29 薬物数 : 25 - (DrugBank : 11) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 20
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02233322
(ClinicalTrials.gov)
August 201427/8/2014Iron Therapy for Autosomal Dominant Hypophosphatemic Rickets: A Pilot Project.Iron Therapy for Autosomal Dominant Hypophosphatemic Rickets: A PilotAutosomal Dominant Hypophosphatemic RicketsDietary Supplement: IronIndiana UniversityNULLCompleted25 MonthsN/AAll8N/AUnited States

254. ポルフィリン症


臨床試験数 : 70 薬物数 : 55 - (DrugBank : 19) / 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
1NCT02979249
(ClinicalTrials.gov)
December 201629/11/2016Oral Iron for Erythropoietic ProtoporphyriasEffect of Oral Iron Therapy on Erythrocyte Protoporphyrin Levels in the Erythropoietic ProtoporphyriasErythropoietic Protoporphyria;EPP;X-linked Protoporphyria;XLPDrug: Oral IronIcahn School of Medicine at Mount SinaiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 YearsN/AAll16N/AUnited States
2NCT01284946
(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 : 37 薬物数 : 110 - (DrugBank : 34) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 123
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-006322-25-GB
(EUCTR)
08/10/201214/08/2012Extending the treatment of Iron OverloadA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
1500Phase 2Egypt;United States;Canada;Thailand;Lebanon;Turkey;Italy;United Kingdom
2EUCTR2011-006322-25-IT
(EUCTR)
20/08/201203/09/2012Extension to the treatment of iron overload with chelation therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
1500Phase 3United States;United Kingdom;Italy
3EUCTR2011-005675-16-IT
(EUCTR)
15/05/201202/08/2012Treatment 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Canada;Lebanon;Turkey;Italy
4EUCTR2010-019645-25-IT
(EUCTR)
04/08/201015/07/2010A 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. - NDA 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.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United Kingdom;Italy
5EUCTR2010-019645-25-GB
(EUCTR)
19/07/201016/06/2010A 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 LLCNULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Thailand;Turkey;Italy;United Kingdom
6EUCTR2007-000766-20-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
7NCT00673608
(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
8NCT00235391
(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