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

  
8 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002840-26-DE
(EUCTR)
15/01/202101/10/2020Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasisA 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2Spain;Germany;United Kingdom;China
2EUCTR2019-002840-26-GB
(EUCTR)
22/12/202003/09/2020Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasisA 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2Spain;Germany;China;United Kingdom
3EUCTR2011-005085-37-FR
(EUCTR)
21/05/201517/06/2015Safety, 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 AGNULLNot RecruitingFemale: yes
Male: yes
140United States;France;Belgium;Ireland;Germany;United Kingdom
4EUCTR2011-005085-37-BE
(EUCTR)
06/05/201526/03/2015Safety, 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 AGNULLNot RecruitingFemale: yes
Male: yes
156France;United States;Belgium;Ireland;United Kingdom
5EUCTR2011-005085-37-IE
(EUCTR)
05/06/201410/04/2014Safety, 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 AGNULLNot RecruitingFemale: yes
Male: yes
156France;United States;Belgium;Ireland;United Kingdom
6EUCTR2011-005085-37-DE
(EUCTR)
09/05/201431/03/2014Safety, 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 AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 1;Phase 2France;United States;Belgium;Ireland;Germany;United Kingdom
7NCT02190604
(ClinicalTrials.gov)
July 31, 201211/7/2014Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis PatientsA 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 PatientsCystic FibrosisDrug: Placebo;Drug: QBW251Novartis PharmaceuticalsNULLTerminated18 Years65 YearsAll153Phase 1/Phase 2United States;Belgium;France;Germany;Ireland;Romania;United Kingdom;Netherlands
8EUCTR2011-005085-37-GB
(EUCTR)
20/07/201224/05/2012Safety, 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 AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 1;Phase 2United States;France;Belgium;Ireland;Romania;Netherlands;Germany;United Kingdom