299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


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

  
21 trials found
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1NCT04731272
(ClinicalTrials.gov)
April 20, 202126/1/2021GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose IntoleranceEffect of GLP-1 Agonist Therapy on Insulin Secretion in Adults With Pancreatic Insufficient Cystic Fibrosis and Abnormal Glucose Tolerance: a Randomized, Open-label, Cross-over TrialCystic Fibrosis;Pancreatic Insufficiency;Abnormal Glucose Tolerance;DiabetesDrug: Dulaglutide 0.75Mg/0.5Ml Inj PenUniversity of PennsylvaniaChildren's Hospital of PhiladelphiaRecruiting18 YearsN/AAll30Phase 2United States
2NCT04533646
(ClinicalTrials.gov)
March 17, 202123/8/2020Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related DiabetesComparison of Meal-Time Dosing of Rapid Acting Insulin Using Carbohydrate Counting vs. Fixed Doses Utilizing Continuous Glucose Monitoring In Patients With Cystic Fibrosis Related DiabetesCystic Fibrosis-related DiabetesDrug: Insulin;Device: Continuous glucose monitor (CGM)Jagdeesh UllalWake Forest University Health SciencesRecruiting18 Years80 YearsAll20Phase 4United States
3EUCTR2020-003170-44-IT
(EUCTR)
14/12/202015/06/2021NAA Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic FibrosisSubjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;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 Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770)
Product Code: [NA]
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Ivacaftor
Product Name: 150mg IVACAFTOR
Product Code: [VX-770]
INN or Proposed INN: IVACAFTOR
VERTEX PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Czechia;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy
4EUCTR2020-003170-44-CZ
(EUCTR)
03/12/202022/10/2020A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose MetabolismA Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;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 Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770)
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Ivacaftor
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;Czechia;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy
5NCT02653027
(ClinicalTrials.gov)
January 1, 20187/1/2016Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508delA Study of the Effect of Combination Lumacaftor and Ivacaftor on Glucose Tolerance in Persons With Cystic Fibrosis Who Are Homozygous for the Phe508del Cystic Fibrosis Transmembrane Conductance Regulator Mutation.Diabetes;Cystic FibrosisDrug: Lumacaftor-ivacaftor;Other: OGTTMassachusetts General HospitalNULLWithdrawn18 Years65 YearsAll0N/ANULL
6NCT02955888
(ClinicalTrials.gov)
January 3, 201721/10/2016Study of Safety, Tolerability & Efficacy in Cystic Fibrosis Patients With Abnormal Glucose ToleranceA Phase 2, Double-Blind, Placebo Controlled Study to Evaluate the Safety & Tolerability of PBI-4050 and Its Effects on Pancreatic and Pulmonary Function in Cystic Fibrosis Patients With Abnormal Glucose ToleranceCystic FibrosisDrug: PBI4050;Drug: PlaceboLiminal BioSciences Ltd.NULLTerminated18 YearsN/AAll11Phase 2Canada
7NCT03512119
(ClinicalTrials.gov)
February 11, 201615/1/2018Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-IvacaftorObservational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-IvacaftorCystic Fibrosis Homozygous for Phe 508 Del CFTR;Glucose Intolerance or Newly Diagnosis DiabetesDrug: Lumacaftor-Ivacaftor treatmentUniversity Hospital, Strasbourg, FranceNULLCompleted12 YearsN/AAll55France
8NCT01975259
(ClinicalTrials.gov)
December 201311/9/2013Investigating the Incretin Effect in Cystic FibrosisInvestigating the Incretin Effect in Cystic FibrosisCystic FibrosisDrug: Oral Glucose Tolerance test (75g 2-hour);Drug: Modified Oral Glucose Tolerance Test (50g 4-hours);Drug: Matched isoglycemic clamp;Drug: Hyperglycemic clamp with concurrent GLP-1 infusion;Drug: Hyperglycemic Clamp with concurrent GIP infusion;Drug: Hyperglycemic clamp with placebo infusion;Other: Liquid Meal Test (Carbohydrate-rich);Other: Liquid Meal Test (Fat-rich);Other: Liquid Meal Test (Mixed);Device: Continuous Glucose MonitoringLiverpool Heart and Chest Hospital NHS Foundation TrustNULLCompleted17 Years50 YearsBoth50N/AUnited Kingdom
9EUCTR2011-002719-27-IT
(EUCTR)
30/12/201113/03/2012EFFECT OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I ON GLUCOSE TOLERANCE AND AS PREVENTION TOWARDS THE DEVELOPMENT OF CYSTIC FIBROSIS RELATED DIABETES MELLITUSGLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS - RH-IGF-I IN CYSTIC FIBROSIS PATIENTS WITH CYSTIC FIBROSIS
MedDRA version: 14.1;Level: PT;Classification code 10011766;Term: Cystic fibrosis pancreatic;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: INCRELEX*SC 1FL 4ML 10MG/ML
INN or Proposed INN: MECASERMIN
AZIENDA OSPEDALIERA DI PARMANULLNot RecruitingFemale: yes
Male: yes
20Italy
10NCT01149005
(ClinicalTrials.gov)
June 20109/6/2010Cystic Fibrosis (CF) Exacerbation and Insulin TreatmentEvaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary ExacerbationCystic Fibrosis;Impaired Glucose Tolerance;Pulmonary ExacerbationDrug: novorapid / humalog short acting insulin;Drug: Novo Rapid Insulin (Novonordisk)Hadassah Medical OrganizationNULLNot yet recruiting10 YearsN/ABoth30N/AIsrael
11NCT00967798
(ClinicalTrials.gov)
May 201027/8/2009Prevention of Cystic Fibrosis DiabetesA Randomized, Double-blind, Placebo-controlled Study to Determine Whether Chronic Treatment of Cystic Fibrosis Subjects With Impaired Glucose Tolerance Using Sitagliptin (Januvia) Prevents the Development of DiabetesCystic Fibrosis;PrediabetesDrug: SitagliptinEmory UniversityNULLTerminated13 YearsN/AAll33Phase 3United States;Canada
12EUCTR2007-004956-35-GB
(EUCTR)
27/08/200826/11/2007The effect of intensive blood glucose control with insulin on markers of short and medium term outcomes in patients hospitalised with acute exacerbations of chronic lung disease. Pilot Study to test feasibility and safety of a clinical protocol for intensive blood glucose control with insulin on medical wards - Pilot of Intensive Blood Glucose Control with Insulin on Medical WardsThe effect of intensive blood glucose control with insulin on markers of short and medium term outcomes in patients hospitalised with acute exacerbations of chronic lung disease. Pilot Study to test feasibility and safety of a clinical protocol for intensive blood glucose control with insulin on medical wards - Pilot of Intensive Blood Glucose Control with Insulin on Medical Wards Acute exacerbations of chronic obstructive pulmonary disease. Stress hyperglycaemia. Insulin-induced hypoglycaemia. Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10010953;Term: COPD exacerbation
MedDRA version: 9.1;Classification code 10060439;Term: Stress induced hyperglycaemia
MedDRA version: 9.1;Classification code 10022484;Term: Insulin hypoglycaemia
MedDRA version: 9.1;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Actrapid 100 IU/ml, Solution for injection in a vial
Trade Name: Levemir 100 U/ml solution for injection in a cartridge, Levemir 100 U/ml solution for injection in a pre-filled pen
Trade Name: NovoRapid 100 U/ml, solution for injection in a vial. NovoRapid Penfill 100 U/ml, solution for injection in a cartridge. NovoRapid FlexPen 100 U/ml, solution for injection in a pre-filled pen.
Trade Name: Lantus® 100 Units/ml solution for injection in a vial. Lantus® 100 Units/ml solution for injection in a cartridge. Lantus® 100 Units/ml solution for injection in a pre-filled pen
St George's, University of LondonNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
13EUCTR2005-002997-31-GB
(EUCTR)
10/08/200609/11/2005A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetesA multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes Individuals with cystic fibrosis develop diabetes. They exhibit abnormal glucose handling (impaired glucose tolerance), poor growth and a decline in lung function before overt diabetes develops. Early treatment with insulin before diabetes develops may improve weight gain and lung function and delay progression to overt diabetes.Product Name: Levemir PenfillSheffield Children's NHS TrustNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
14NCT00287456
(ClinicalTrials.gov)
February 2, 20062/2/2006Use of the Insulin Pump in Cystic Fibrosis Patients With Impaired Glucose Tolerance or CFRD and in Type 1 Diabetes Patients.Cystic Fibrosis Related DiabetesDevice: Insulin Pump;Drug: Insulin;Procedure: Oral Glucose Tolerance Test;Procedure: Whole body Protein TurnoverUniversity of Texas Southwestern Medical CenterNULLWithdrawn12 Years32 YearsAll0N/AUnited States
15NCT00483769
(ClinicalTrials.gov)
February 20066/6/2007One Year Glargine Treatment in CFRD Children and AdolescentsOne-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose DerangementsCystic Fibrosis;Glucose Metabolism DisordersDrug: GlargineFederico II UniversityNULLCompleted3 Years20 YearsBoth20Phase 4Italy
16EUCTR2005-002135-27-IT
(EUCTR)
06/07/200528/06/2005Glargine insulin efficacy in Cystic Fibrosis patients with glucose intolerance and clinical deteriorationGlargine insulin efficacy in Cystic Fibrosis patients with glucose intolerance and clinical deterioration Cystic Fibrosis patients with glucose intolerance
MedDRA version: 6.1;Level: PT;Classification code 10011762
Trade Name: LANTUS*SC 5CAR3ML100UI/ML
Product Name: NA
Product Code: NA
INN or Proposed INN: Insulin glargine
ISTITUTO GIANNINA GASLININULLNot RecruitingFemale: yes
Male: yes
Italy
17EUCTR2004-005019-28-GB
(EUCTR)
09/05/200519/04/2005Diabetes therapy to improve body mass index pulmoanry function in cystic fibrosis subjects with abnormal blood glucoseDiabetes therapy to improve body mass index pulmoanry function in cystic fibrosis subjects with abnormal blood glucose Cystic fibrosis related diabetes mellitusTrade Name: NovoRapid Aspartate
INN or Proposed INN: Novo Rapid
Trade Name: Rapeglinide
INN or Proposed INN: Rapeglinide
Papworth Hospital NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
6 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
18NCT00014768
(ClinicalTrials.gov)
February 200110/4/2001Study of Metabolic Effects of Pregnancy in Women With Cystic FibrosisCystic FibrosisDrug: glucose;Drug: insulin;Drug: leucineNational Center for Research Resources (NCRR)University of UtahTerminatedN/AN/AFemale36N/AUnited States
19EUCTR2020-003170-44-BE
(EUCTR)
16/10/2020A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose MetabolismA Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;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 Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770)
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Ivacaftor
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
60Phase 3France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy
20EUCTR2020-003170-44-FR
(EUCTR)
22/10/2020A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose MetabolismA Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;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 Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770)
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Ivacaftor
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
60Phase 3France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy
21EUCTR2020-003170-44-NL
(EUCTR)
09/11/2020A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose MetabolismA Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;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 Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770)
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Ivacaftor
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
60Phase 3France;Czechia;Spain;Belgium;Australia;Netherlands;Italy