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 | EUCTR2019-002840-26-DE (EUCTR) | 15/01/2021 | 01/10/2020 | Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasis | A randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis | Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QBW251 INN or Proposed INN: Icenticaftor Other descriptive name: CFTR potentiator | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | Spain;Germany;United Kingdom;China | ||
| 2 | EUCTR2019-002840-26-GB (EUCTR) | 22/12/2020 | 03/09/2020 | Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasis | A randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis | Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QBW251 INN or Proposed INN: Icenticaftor Other descriptive name: CFTR potentiator | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | Spain;Germany;China;United Kingdom | ||
| 3 | EUCTR2011-005085-37-FR (EUCTR) | 21/05/2015 | 17/06/2015 | Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients. | A randomized, double blind placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients | cystic fibrosis MedDRA version: 18.0;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] | Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | United States;France;Belgium;Ireland;Germany;United Kingdom | |||
| 4 | EUCTR2011-005085-37-BE (EUCTR) | 06/05/2015 | 26/03/2015 | Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients. | A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients | 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 Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | France;United States;Belgium;Ireland;United Kingdom | |||
| 5 | EUCTR2011-005085-37-IE (EUCTR) | 05/06/2014 | 10/04/2014 | Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients. | A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients | cystic fibrosis MedDRA version: 16.1;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 Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | France;United States;Belgium;Ireland;United Kingdom | |||
| 6 | EUCTR2011-005085-37-DE (EUCTR) | 09/05/2014 | 31/03/2014 | Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients. | A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients | cystic fibrosis MedDRA version: 18.1;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 Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 1;Phase 2 | France;United States;Belgium;Ireland;Germany;United Kingdom | ||
| 7 | NCT02190604 (ClinicalTrials.gov) | July 31, 2012 | 11/7/2014 | Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients | A Randomized, Double Blind Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Ascending Doses of QBW251 in Healthy Subjects and Multiple Doses in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Placebo;Drug: QBW251 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 153 | Phase 1/Phase 2 | United States;Belgium;France;Germany;Ireland;Romania;United Kingdom;Netherlands |
| 8 | EUCTR2011-005085-37-GB (EUCTR) | 20/07/2012 | 24/05/2012 | Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients. | A randomized, double blind placebo-controlled study to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients. | cystic fibrosis MedDRA version: 17.0;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] | Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 1;Phase 2 | United States;France;Belgium;Ireland;Romania;Netherlands;Germany;United Kingdom |