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 | 5 |
| 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 | NCT03318159 (ClinicalTrials.gov) | April 20, 2018 | 10/10/2017 | Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients | Open Label, Phase II Study Investigating the Efficacy of Posaconazole as Prophylaxis Antifungal Agent in Aplastic Anemia / Hypoplastic Myelodysplastic Syndrome Patients Undergoing Antithymocyte Globulin Treatment | Aplastic Anemia;Myelodysplastic Syndromes;Fungal Infection | Drug: Posaconazole | Seoul National University Hospital | Merck Sharp & Dohme Corp. | Unknown status | 18 Years | 75 Years | All | 40 | Phase 2 | Korea, Republic of |
| 2 | NCT02875743 (ClinicalTrials.gov) | December 7, 2016 | 18/8/2016 | King's Invasive Aspergillosis Study II | Incidence of Invasive Fungal Disease in Patients Receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis | Aplastic Anemia;Leukemia, Myeloid, Acute;Myelodysplastic Syndromes;Bone Marrow Transplantation | Drug: Posaconazole | King's College Hospital NHS Trust | NULL | Completed | 18 Years | N/A | All | 120 | Phase 4 | United Kingdom |
| 3 | EUCTR2016-001223-31-GB (EUCTR) | 11/10/2016 | 07/09/2016 | Incidence of Invasive Fungal Disease in Patients receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole tablet Prophylaxis | Incidence 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | 150 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2008-004518-28-GB (EUCTR) | 08/12/2009 | 09/11/2009 | Investigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD) - iPOD | Investigation 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 Centre | NULL | Not Recruiting | Female: yes Male: yes | 20 | United Kingdom;Netherlands | |||
| 2 | NCT00799071 (ClinicalTrials.gov) | February 2009 | 26/11/2008 | Pharmacokinetics 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 Disease | Drug: posaconazole (PSZ) | Radboud University | NULL | Completed | 2 Years | 16 Years | All | 12 | Phase 2 | Netherlands;United Kingdom |
| 3 | EUCTR2008-004518-28-NL (EUCTR) | 19/11/2008 | 24/11/2008 | Investigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD) - iPOD | Investigation 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 | Radboud University Nijmegen Medical Centre | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom;Netherlands |
| 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 | EUCTR2019-004511-31-IT (EUCTR) | 21/10/2020 | 07/10/2020 | Prospective 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 ROMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;Czech Republic;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 2 | EUCTR2018-002579-16-SE (EUCTR) | 26/08/2018 | 16/07/2018 | Measurement 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 center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Sweden | ||
| 3 | NCT03421366 (ClinicalTrials.gov) | March 1, 2018 | 27/12/2017 | Modified Release Posaconazole in Patients With Cystic Fibrosis | Modified Release Posaconazole in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Posaconazole | Bayside Health | NULL | Recruiting | 18 Years | N/A | All | 20 | Australia | |
| 4 | EUCTR2012-003140-68-GB (EUCTR) | 29/10/2012 | 28/09/2012 | A 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 | MSD | NULL | Not Recruiting | Female: yes Male: yes | 40 | United Kingdom | |||
| 5 | EUCTR2019-004511-31-GB (EUCTR) | 06/10/2020 | Prospective 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 Hospital | NULL | NA | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;Czech Republic;Greece;Spain;Ireland;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden |