Ferric carboxymaltose ( DrugBank: Ferric carboxymaltose )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
86肺動脈性肺高血圧症4
96クローン病1
97潰瘍性大腸炎1
299嚢胞性線維症2

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-024585-22-DE
(EUCTR)
01/12/201617/08/2016What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? - Ferinject® for iron deficiency in IPAH patients Idiopathic or familial pulmonary arterial hypertension
MedDRA version: 19.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Ferinject
Product Name: Ferinject
INN or Proposed INN: FERRIC CARBOXYMALTOSE
Imperial College Academic Healthsciences CentreNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Germany;United Kingdom
2NCT01847352
(ClinicalTrials.gov)
February 20131/5/2013Iron Status and Hypoxic Pulmonary Vascular ResponsesEffect of Endogenous Iron Status on Hypoxic Pulmonary Vascular Responses and Their Attenuation by Intravenous IronLung Hypoxia;Pulmonary Arterial Hypertension;Iron DeficiencyDrug: Intravenous administration of ferric carboxymaltose;Other: Subacute hypoxic exposuresUniversity of OxfordNational Institute for Health Research, United Kingdom;British Heart FoundationCompleted18 YearsN/ABoth31N/AUnited Kingdom
3EUCTR2010-024585-22-GB
(EUCTR)
25/03/201125/02/2011What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? - Ferinject® for iron deficiency in IPAH patients Idiopathic or familial pulmonary arterial hypertension
MedDRA version: 18.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Ferinject
Product Name: Ferinject
INN or Proposed INN: Ferric carboxymaltose
Imperial College Academic Healthsciences CentreNULLNot Recruiting Female: yes
Male: yes
Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany;United Kingdom
4EUCTR2010-023233-30-NL
(EUCTR)
13/12/201006/10/2010‘Intravenous iron treatment in iron deficient patients with pulmonary arterialhypertension' - Treating iron deficiency in PAH‘Intravenous iron treatment in iron deficient patients with pulmonary arterialhypertension' - Treating iron deficiency in PAH Objective: To evaluate the effects of intravenous iron suppletion in iron deficient IPAH patients.Study design: Intervention studyStudy population: Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiencyIntervention:Patients receive a weekly iron bolus infusion until iron levels are restored (correction phase). Then a maintenance dose is given once per month (maintenance phase) until the endpoint after 20 weeks.
MedDRA version: 12.1;Level: LLT;Classification code 10064909;Term: Idiopathic (IPAH)
Trade Name: Ferinject
Product Name: Ferric carboxymaltose
Product Code: RVG 33865
VU university medical centerNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Netherlands

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00810030
(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

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00810030
(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

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03632525
(ClinicalTrials.gov)
February 22, 201921/6/2018Intravenous Iron in Adults With Cystic FibrosisA Pilot Trial of Intravenous Iron for the Treatment of Iron Deficiency in Adult Patients With Cystic FibrosisCystic Fibrosis;Iron-deficiencyDrug: Ferric carboxymaltoseUniversity of OxfordNULLCompleted18 YearsN/AAll20Phase 4United Kingdom
2EUCTR2018-002366-39-GB
(EUCTR)
23/08/201820/06/2019A pilot trial of intravenous iron for the treatment of low iron levels in adult patients with cystic fibrosis.A pilot trial of intravenous iron for the treatment of iron deficiency in adult patients with cystic fibrosis - Intravenous iron in adults with cystic fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ferinject
Product Name: Ferinject
INN or Proposed INN: Ferric carboxymaltose
University of Oxford / Clinical Trials and Research GovernanceNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom