299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,696 / 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
| 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 | NCT03698448 (ClinicalTrials.gov) | December 1, 2020 | 3/10/2018 | A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic Fibrosis | A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: OligoG Dry powder for inhalation | AlgiPharma AS | Imperial College London;Cystic Fibrosis Foundation;European Cystic Fibrosis Society;University Hospital of Cologne;Cystic Fibrosis Europe | Not yet recruiting | 12 Years | N/A | All | 120 | Phase 2/Phase 3 | Germany |
| 2 | EUCTR2018-000378-30-DE (EUCTR) | 04/03/2020 | 06/06/2019 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20, 17,5 mg, Hartkapsel mit Pulver zur Inhalation INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20, 27,5 mg, Hartkapsel mit Pulver zur Inhalation INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20, 37,5 mg, Hartkapsel mit Pulver zur Inhalation INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | ||
| 3 | EUCTR2018-000378-30-GB (EUCTR) | 03/03/2020 | 26/06/2019 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 - 17.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 27.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 37.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 | AlgiPharma AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 168 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | ||
| 4 | EUCTR2018-000378-30-AT (EUCTR) | 04/11/2019 | 05/07/2019 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | ||
| 5 | NCT03822455 (ClinicalTrials.gov) | May 16, 2019 | 29/1/2019 | A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis | A Phase 2b Randomised, Double-blind, Parallel-group Study of Alginate Oligosaccharide (OligoG) Dry Powder Inhalation in Addition to Standard of Care Compared to Placebo in Addition to Standard of Care in Patients With Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: OligoG DPI | AlgiPharma AS | AlgiPharma Australia Pty. Ltd. | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 2 | Australia |
| 6 | NCT02453789 (ClinicalTrials.gov) | February 2015 | 14/5/2015 | A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection | A Randomized Double-blind, Placebo-controlled Cross-over Study of Inhaled Alginate Oligosaccharide (OligoG) for 28 Days in Subjects With Cystic Fibrosis Using Aztreonam Due to Chronic Colonization With Burkholderia Spp. | Cystic Fibrosis;Burkholderia Infection | Drug: Alginate oligosaccharide;Drug: Placebo | AlgiPharma AS | NULL | Completed | 18 Years | N/A | All | 15 | Phase 2 | Germany |
| 7 | EUCTR2014-002125-35-DE (EUCTR) | 18/12/2014 | 21/07/2014 | A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp. | A randomized double-blind, placebo-controlled cross-over study of inhaled alginate oligosaccharide (OligoG) for 28 days in subjects with Cystic Fibrosis using aztreonam due to chronic colonization with Burkholderia spp. - A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp. | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 INN or Proposed INN: Oligomer of Sodium Alginate Other descriptive name: OLIGOG CF-5/20 | Algipharma AS | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Germany | ||
| 8 | EUCTR2014-000844-13-SE (EUCTR) | 21/10/2014 | 21/07/2014 | A phase IIb study of OligoG in subjects with cystic fibrosis | A double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosis | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 INN or Proposed INN: Oligomer of Sodium Alginate Other descriptive name: OLIGOG CF-5/20 | Algipharma AS | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 2 | Denmark;Germany;Sweden | ||
| 9 | NCT02157922 (ClinicalTrials.gov) | October 2014 | 4/6/2014 | A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis | A Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: alginate oligosaccharide | AlgiPharma AS | Eurostars;Smerud Medical Research International AS | Completed | 18 Years | N/A | All | 65 | Phase 2 | Denmark;Germany;Norway;Sweden;United Kingdom |
| 10 | EUCTR2014-000844-13-DK (EUCTR) | 25/09/2014 | 08/07/2014 | A phase IIb study of OligoG in subjects with cystic fibrosis | A double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosis | Cystic Fibrosis MedDRA version: 17.1;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] | Product Name: OligoG CF-5/20 INN or Proposed INN: Oligomer of Sodium Alginate Other descriptive name: OLIGOG CF-5/20 | Algipharma AS | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 2 | Denmark;Germany;Sweden | ||
| 11 | NCT01991028 (ClinicalTrials.gov) | April 2014 | 18/11/2013 | A Study to Investigate Lung Deposition of Radiolabelled OligoG | An Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Radiolabelled OligoG CF-5/20 DPI;Drug: Radiolabelled OligoG CF-5/20 6% Solution | Bio-Images Research Ltd | AlgiPharma AS | Completed | 18 Years | N/A | Both | 10 | Phase 2 | United Kingdom |
| 12 | EUCTR2013-003774-27-GB (EUCTR) | 20/01/2014 | 27/11/2013 | A study to investigate lung deposition of radiolabelled OligoG(v1.0) | An open label, randomised, two-way crossover scintigraphic study to investigate lung deposition of radiolabelled OligoG delivered as a dry powder and as a nebulised solution in cystic fibrosis patients - A study to investigate lung deposition of radiolabelled OligoG (v1.0) | Cystic fibrosis (CF) is an autosomal, recessive inheritable disease caused by a homozygote defect at the long arm of Chromosome 7. This mutation causes absence or defect of the cystic fibrosis transmembrane conductance regulator, an ion channel transporting chloride and bicarbonate ions across the cell membrane in exocrine glands. Decreased chloride transport leads to dehydration of the mucus layer, and decreased bicarbonate to increased mucus adhesion. Mucus stagnation results.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Radiolabelled OligoG CF-5/20 Dry Powder for Inhalation (DPI) INN or Proposed INN: OligoG Product Name: Radiolabelled OligoG CF-5/20 6% Solution for Nebulisation INN or Proposed INN: OligoG | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | United Kingdom | ||
| 13 | NCT01465529 (ClinicalTrials.gov) | May 2011 | 31/10/2011 | A Cross-over Study of OligoG in Subjects With Cystic Fibrosis. Fibrosis | A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: OligoG CF-5/20;Drug: Saline | AlgiPharma AS | NULL | Completed | 18 Years | N/A | Both | 26 | Phase 1/Phase 2 | Ireland;United Kingdom |
| 14 | EUCTR2010-023090-19-IE (EUCTR) | 08/04/2011 | 15/02/2011 | A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa | A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosis | Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: OligoG (60 mg/ml) Product Code: OligoG INN or Proposed INN: Sodium alginate Other descriptive name: SODIUM ALGINATE | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Ireland;United Kingdom | ||
| 15 | EUCTR2010-023090-19-GB (EUCTR) | 29/03/2011 | 11/02/2011 | A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa | A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosis | Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: OligoG (60 mg/ml) Product Code: OligoG INN or Proposed INN: OligoG Other descriptive name: OligoG-CF5/20, Alginate oligosaccharide (G-block) fragment | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Ireland;United Kingdom | ||
| 16 | NCT00970346 (ClinicalTrials.gov) | September 2009 | 1/9/2009 | Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis | A Randomised, Double-blind, Placebo-controlled Dose-escalation Phase I Study to Evaluate the Safety and Tolerability of Inhaled Aerosolised OligoG CF-5/20 (G-block Oligosaccharide Derived From Alginate Polysaccharide) in Healthy Volunteers | Cystic Fibrosis | Drug: OligoG CF-5/20 | AlgiPharma AS | Smerud Medical Research International AS | Completed | 18 Years | 65 Years | Male | 26 | Phase 1 | United Kingdom |
| 17 | EUCTR2018-000378-30-IE (EUCTR) | 26/06/2019 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 - 17.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 27.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 37.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | |||
| 18 | EUCTR2018-000378-30-PL (EUCTR) | 01/06/2020 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 | AlgiPharma AS | NULL | NA | Female: yes Male: yes | 180 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom |