Posaconazole ( DrugBank: Posaconazole )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
60再生不良性貧血3
65原発性免疫不全症候群3
299嚢胞性線維症13

60. 再生不良性貧血


臨床試験数 : 245 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03318159
(ClinicalTrials.gov)
April 20, 201810/10/2017Posaconazole Prophylaxis During ATG Treatment for hMDS/AA PatientsOpen Label, Phase II Study Investigating the Efficacy of Posaconazole as Prophylaxis Antifungal Agent in Aplastic Anemia / Hypoplastic Myelodysplastic Syndrome Patients Undergoing Antithymocyte Globulin TreatmentAplastic Anemia;Myelodysplastic Syndromes;Fungal InfectionDrug: PosaconazoleSeoul National University HospitalMerck Sharp & Dohme Corp.Unknown status18 Years75 YearsAll40Phase 2Korea, Republic of
2NCT02875743
(ClinicalTrials.gov)
December 7, 201618/8/2016King's Invasive Aspergillosis Study IIIncidence of Invasive Fungal Disease in Patients Receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole ProphylaxisAplastic Anemia;Leukemia, Myeloid, Acute;Myelodysplastic Syndromes;Bone Marrow TransplantationDrug: PosaconazoleKing's College Hospital NHS TrustNULLCompleted18 YearsN/AAll120Phase 4United Kingdom
3EUCTR2016-001223-31-GB
(EUCTR)
11/10/201607/09/2016Incidence of Invasive Fungal Disease in Patients receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole tablet ProphylaxisIncidence of Invasive Fungal Disease in Patients receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis - King's Invasive Aspergillosis Study II (KIASII) Aplastic Anaemia, Myelodysplastic syndromes, Acute Myeloid Leukaemia undergoing immunosuppression therapy, high dose chemotherapy or reduced intensity stem cell transplantation
MedDRA version: 19.0;Level: LLT;Classification code 10038271;Term: Refractory anaemia with excess blasts in transformation;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.0;Classification code 10059041;Term: Allogeneic peripheral haematopoietic stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 19.0;Classification code 10067862;Term: Allogeneic stem cell transplantation;Level: PT;Classification code 10038270;Term: Refractory anaemia with an excess of blasts;Classification code 10010776;Term: Constitutional aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 19.0;Classification code 10068063;Term: Aplastic anaemia relapse;Classification code 10036699;Term: Primary idiopathic aplastic anaemia;Classification code 10000880;Term: Acute myeloid leukaemia;Classification code 10001756;Term: Allogenic bone marrow transplantation therapy;Classification code 10000884;Term: Acute myeloid leukaemia NOS;System Organ Class: 10029104 - ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Noxafil®
Product Name: Noxafil Gastro resistant tablets
King's College Hospital NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United Kingdom

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-004518-28-GB
(EUCTR)
08/12/200909/11/2009Investigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD) - iPODInvestigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD) - iPOD Children with chronic granulomatous disease (CGD).
MedDRA version: 9.1;Level: LLT;Classification code 10008906;Term: Chronic granulomatous disease
Trade Name: Noxafil 40 mg/ml oral solution
Product Name: noxafil
INN or Proposed INN: POSACONAZOLE
Radboud University Nijmegen Medical CentreNULLNot RecruitingFemale: yes
Male: yes
20United Kingdom;Netherlands
2NCT00799071
(ClinicalTrials.gov)
February 200926/11/2008Pharmacokinetics of Posaconazole in Children With Chronic Granulomatous Disease (CGD)Investigation of POsaconazole Prophylaxis in Children With Chronic Granulomatous Disease (CGD): Pharmacokinetics and Tolerability (iPOD)Chronic Granulomatous DiseaseDrug: posaconazole (PSZ)Radboud UniversityNULLCompleted2 Years16 YearsAll12Phase 2Netherlands;United Kingdom
3EUCTR2008-004518-28-NL
(EUCTR)
19/11/200824/11/2008Investigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD) - iPODInvestigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD) - iPOD Children with chronic granulomatous disease (CGD).
MedDRA version: 9.1;Level: LLT;Classification code 10008906;Term: Chronic granulomatous disease
Trade Name: Noxafil 40 mg/ml oral solutionRadboud University Nijmegen Medical CentreNULLNot RecruitingFemale: yes
Male: yes
United Kingdom;Netherlands

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
1EUCTR2019-004511-31-ES
(EUCTR)
31/01/202230/08/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
Trade Name: Noxafil 100 mg
Product Name: Noxafil
Bambino Gesù Children´s HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
2EUCTR2019-004511-31-DE
(EUCTR)
10/01/202230/07/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
INN or Proposed INN: Posaconazole
Other descriptive name: Posaconazole
Trade Name: Noxafil 100 mg
Product Name: Noxafil
INN or Proposed INN: Posaconazole
Other descriptive name: Posaconazole
Bambino Gesù Children's HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
3EUCTR2019-004511-31-NL
(EUCTR)
03/01/202229/04/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
Trade Name: Noxafil 100 mg
Product Name: Noxafil
Bambino Gesù Children's HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden
4EUCTR2019-004511-31-GR
(EUCTR)
16/09/202104/03/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
Trade Name: Noxafil 100 mg
Product Name: Noxafil
Bambino Gesù Children's HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
5EUCTR2019-004511-31-PT
(EUCTR)
18/06/202118/01/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
Trade Name: Noxafil 100 mg
Product Name: Noxafil
Bambino Gesù Children's HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3France;Portugal;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
6NCT04966234
(ClinicalTrials.gov)
April 22, 202119/3/2021A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus InfectionProspective Validation and Clinical Evaluation of a New Posaconazole Dosing Regimen for Children and Adolescents With Cystic Fibrosis and Aspergillus InfectionCystic Fibrosis;AspergillosisDrug: Posaconazole 100 MG [Noxafil];Drug: Posaconazole 40 MG/MLBambino Gesù Hospital and Research InstituteUniversity of Exeter;Radboud University;Consorzio per Valutazioni Biologiche e FarmacologicheRecruiting8 Years17 YearsAll135Phase 2/Phase 3Czechia;France;Germany;Greece;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom
7EUCTR2019-004511-31-IT
(EUCTR)
21/10/202007/10/2020Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - 40 MG/ML SOSPENSIONE ORALE USO ORALE FLACONE (VETRO) 105 ML 1 FLACONE
Product Name: Noxafil
Product Code: [NA]
INN or Proposed INN: Posaconazolo
Trade Name: Noxafil
Product Name: Noxafil
Product Code: [NA]
INN or Proposed INN: POSACONAZOLO
Trade Name: Noxafil
Product Name: Noxafil
Product Code: [NA]
INN or Proposed INN: POSACONAZOLO
Product Name: Noxafil
Product Code: [na]
INN or Proposed INN: POSACONAZOLO
Trade Name: NOXAFIL - 40 MG/ML SOSPENSIONE ORALE USO ORALE FLACONE (VETRO) 105 ML 1 FLACONE
Product Name: Noxafil
Product Code: [na]
INN or Proposed INN: POSACONAZOLO
Trade Name: Noxafil
Product Name: Noxafil
Product Code: [na]
INN or Proposed INN: Posaconazolo
IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMANULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czech Republic;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
8EUCTR2018-002579-16-SE
(EUCTR)
26/08/201816/07/2018Measurement of the posaconazole concentration in exhaled breath in CF patients after a single dose posaconazole to correlate to the concentration in blood and saliva.Evaluation of the possible use of analysis of posaconazole in exhaled breath as a surrogate marker for the lung to monitor adequate dosages of posaconazole in CF patients treated for Aspergillus spp. related lung-disease. Part 1. Pharmacokinetic single center study. Cystic Fibrosis (CF) is the most common life–limiting autosomal recessive disease among people of European heritage. The condition is a result of a mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene on chromosome seven, which encodes a chloride channel. In the lung defective channel activity leads to thick, viscous secretion and impaired mucociliary clearance. This causes trapping of mucus, colonization with bacteria and fungi, and a persistent inflammatory response.
MedDRA version: 20.0;Level: PT;Classification code 10074549;Term: Cystic fibrosis respiratory infection suppression;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Noxafil®Karolinska University Hospital, Stockholm CF centerNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2Sweden
9NCT03421366
(ClinicalTrials.gov)
March 1, 201827/12/2017Modified Release Posaconazole in Patients With Cystic FibrosisModified Release Posaconazole in Patients With Cystic FibrosisCystic FibrosisDrug: PosaconazoleBayside HealthNULLRecruiting18 YearsN/AAll20Australia
10EUCTR2012-003140-68-GB
(EUCTR)
29/10/201228/09/2012A Study to Look at the Way the Body Absorbs and Distributes Posaconazole in the Blood and Lungs of Lung Transplant Recipients (PAPAL Study)A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients - Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients Invasive fungal infection (IFI) in lung transplant patients with and without cystic fibrosis.
MedDRA version: 15.0;Level: PT;Classification code 10049085;Term: Antifungal prophylaxis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Noxafil
Product Name: Noxafil
INN or Proposed INN: Posaconazole
MSDNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom
11EUCTR2019-004511-31-IE
(EUCTR)
21/05/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - 40 mg/ml oral suspension
Product Name: Noxafil
INN or Proposed INN: POSACONAZOLE
Other descriptive name: POSACONAZOLE
Trade Name: Noxafil 100 mg Tablets Gastro-Resistant
Product Name: Noxafil
INN or Proposed INN: POSACONAZOLE
Other descriptive name: POSACONAZOLE
Bambino Gesù Children's HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
12EUCTR2019-004511-31-FR
(EUCTR)
01/04/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
Trade Name: Noxafil 100 mg
Product Name: Noxafil
Bambino Gesù Children's HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
13EUCTR2019-004511-31-GB
(EUCTR)
06/10/2020Prospective validation and clinical evaluation of a new posaconazole dosingregimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus Infection
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Noxafil - oral suspension 40 mg/ml
Product Name: Noxafil - oral suspension 40 mg/ml
Trade Name: Noxafil 100 mg
Product Name: Noxafil 100 mg
Bambino Gesù Children's HospitalNULLNAFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czech Republic;Greece;Spain;Ireland;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden