299. 嚢胞性線維症
[臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162

Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
34 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1NCT04599465
(ClinicalTrials.gov)
January 202121/10/2020A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose MetabolismCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLNot yet recruiting12 YearsN/AAll60Phase 3NULL
2EUCTR2020-003170-44-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 IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy
3NCT04533646
(ClinicalTrials.gov)
December 1, 202023/8/2020Comparison 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 SciencesNot yet recruiting18 Years80 YearsAll20Phase 4NULL
4NCT04579939
(ClinicalTrials.gov)
November 202029/9/2020Oral Glucose Tolerance Testing Using Candy for Cystic FibrosisOral Glucose Tolerance Testing Using Candy: A Sweet Solution to Improve Screening Compliance in Cystic FibrosisCystic FibrosisDiagnostic Test: Candy Glucose Tolerance TestMayo ClinicNULLNot yet recruiting10 Years21 YearsAll10N/AUnited States
5NCT03650712
(ClinicalTrials.gov)
July 1, 201918/7/2018EnVision CF Multicenter Study of Glucose Tolerance in Cystic FibrosisEnVision CF Multicenter Study of Glucose Tolerance in Cystic FibrosisCystic Fibrosis-related DiabetesDiagnostic Test: Oral glucose tolerance test;Diagnostic Test: Continuous glucose monitoring;Diagnostic Test: Dexa scanKatie Larson OdeNULLRecruiting6 YearsN/AAll144N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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PhaseCountries
6NCT03961516
(ClinicalTrials.gov)
May 1, 201916/5/2019Glycemic Characterization and Pancreatic Imaging Correlates in Cystic FibrosisGlycemic Characterization and Pancreatic Imaging Correlates in Cystic FibrosisCystic Fibrosis;Cystic Fibrosis-related Diabetes;Cystic Fibrosis Liver Disease;Pancreatic Steatosis;Hepatic SteatosisDevice: Frequently Sampled Oral Glucose Tolerance Test and CGM;Radiation: MRI Pancreas and LiverUniversity Hospitals Cleveland Medical CenterNULLRecruiting6 Years40 YearsAll40United States
7NCT02653027
(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
8NCT02955888
(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
9NCT03512119
(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
10NCT02703155
(ClinicalTrials.gov)
October 20159/2/2016The Use of Home Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related DiabetesThe Use of Self-Administered Electronic Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes in Children With Cystic FibrosisCystic Fibrosis Related Diabetes;Cystic FibrosisDevice: Home Oral Glucose Tolerance Test kitGreat Ormond Street Hospital for Children NHS Foundation TrustUniversity College, LondonRecruiting10 Years17 YearsBoth30N/AUnited Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
11NCT02569229
(ClinicalTrials.gov)
June 201512/8/2015Glucose Tolerance in Children With Cystic FibrosisGlucose Tolerance and Its Clinical Impact in Children and Adolescents With Cystic FibrosisGlucose Intolerance;Cystic FibrosisOther: Diagnostics for glucose tolerance with 3 different methods.Christoph SanerUniversity Hospital Inselspital, BerneActive, not recruiting10 Years20 YearsAll14Switzerland
12NCT02398383
(ClinicalTrials.gov)
March 201522/1/2015Role of Glucagon In Glucose Control in Cystic Fibrosis Related DiabetesRole of Glucagon in Glucose Control in Cystic Fibrosis Related DiabetesCystic Fibrosis;Cystic Fibrosis Related DiabetesOther: Oral Glucose Tolerance Test;Other: Mixed Meal Tolerance Test;Other: Hypoglycemic ClampYale UniversityNULLCompleted12 Years45 YearsAll7Early Phase 1United States
13NCT02202876
(ClinicalTrials.gov)
November 201425/7/2014Redox Imbalance and the Development of Cystic Fibrosis DiabetesRedox Imbalance and the Development of Cystic Fibrosis DiabetesDiabetes Mellitus, Type 2;Cystic FibrosisOther: Oral Glucose Tolerance Test;Other: High Glycemic Index Meal;Other: Low Glycemic Index Meal;Other: Test Soda;Other: Fruit juiceEmory UniversityCystic Fibrosis FoundationCompleted1 YearN/AAll34N/AUnited States
14NCT01975259
(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
15NCT01883037
(ClinicalTrials.gov)
June 201313/6/2013Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RTTo Compare the Clinical Accuracy of Glucose Measurement During Oral Glucose Tolerance Test Using Two Methods: i) Laboratory Standard Technique, ii) HemoCue Glucose 201 RT SystemCystic FibrosisOther: Blood glucose resultsRoyal Brompton & Harefield NHS Foundation TrustNULLCompleted16 YearsN/ABoth70N/AUnited Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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size
PhaseCountries
16NCT01852448
(ClinicalTrials.gov)
May 20139/5/2013Genetics of Insulin and Incretins in Cystic FibrosisEvaluation of the Enteroinsular Axis in Cystic FibrosisCystic FibrosisGenetic: Blood or Saliva Sample Collection;Other: Glucose -potentiated arginine (GPA) stimulation testsChildren's Hospital of PhiladelphiaUniversity of PennsylvaniaActive, not recruiting2 YearsN/AAll350United States
17EUCTR2011-002719-27-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
18NCT03644199
(ClinicalTrials.gov)
March 30, 201110/5/2016Development of Diabetes in Adults With Cystic Fibrosis (CF)Factors Responsible for the Development of Diabetes in Adults With Cystic FibrosisCystic FibrosisOther: Oral Glucose Tolerance Test (OGTT) assessment arm;Other: Mixed meal test evaluation test armLiverpool Heart and Chest Hospital NHS Foundation TrustNULLWithdrawn18 Years50 YearsAll0N/AUnited Kingdom
19NCT01149005
(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
20NCT00967798
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02723968
(ClinicalTrials.gov)
September 200921/3/2016Cystic Fibrosis Related Diabetes Screening.Sensitivity and Specificity of Different Methods for Cystic Fibrosis-related Diabetes Screening.Cystic Fibrosis-related DiabetesOther: glucose solution at a dose of 1.75 g/kg (up to a maximum of 75 g) for the OGTT and glucose solution at a dose of 0.5 g/kg (up to a maximum of 35 g) was injected in 2.5-3 min for the IGTT;Procedure: HGPIV diagnosis test;Procedure: HOMAR-IR diagnosis testHospices Civils de LyonNULLCompleted10 Years18 YearsAll29N/ANULL
22NCT01091025
(ClinicalTrials.gov)
March 200918/3/2010Comparing Two Different Approaches in the Screening of Cystic Fibrosis Related DiabetesA Comparative Analysis of the Clinical Efficacy of Two Approaches in the Screening for Cystic Fibrosis Related Diabetes in Adult With Cystic Fibrosis: i) a Selective Approach; ii) an Unselected Annual Oral Glucose Tolerance TestScreening of Cystic Fibrosis Related DiabetesOther: Glucose profile for 2 weeksImperial College LondonRoyal Brompton & Harefield NHS Foundation TrustCompleted16 YearsN/AAll100N/AUnited Kingdom
23EUCTR2007-004956-35-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
24NCT00476281
(ClinicalTrials.gov)
April 200818/5/2007Nutritional, Metabolic and Respiratory Status in Cystic FibrosisMulticenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic FibrosisCystic Fibrosis;DiabetesProcedure: Urinary collect;Procedure: Continuous Glucose Monitoring System (CGMS)University Hospital, Strasbourg, FranceAssociation d'Aide aux Insuffisants Respiratoires d'Alsace LorraineCompleted10 YearsN/AAll114N/AFrance
25EUCTR2005-002997-31-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.Sheffield Children's NHS TrustNULLNot Recruiting Female: yes
Male: yes
40Phase 4United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
26NCT00287456
(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
27NCT00287443
(ClinicalTrials.gov)
February 2, 20062/2/2006Metabolic Abnormalities in Hispanic Children With Cystic FibrosisCystic FibrosisProcedure: Oral Glucose tolerance test;Procedure: Whole body protein turnover;Procedure: IV glucose tolerance test;Procedure: Indirect Calorimetry;Procedure: Dual Energy X-ray Absorptiometry (DEXA);Procedure: Growth Hormone Stimulation TestUniversity of Texas Southwestern Medical CenterGenentech, Inc.Withdrawn7 Years17 YearsAll0N/AUnited States
28NCT00483769
(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
29EUCTR2005-002135-27-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
30EUCTR2004-005019-28-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 mellitusPapworth Hospital NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
6Phase 4United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT00014768
(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
32EUCTR2020-003170-44-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
33EUCTR2020-003170-44-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
34EUCTR2020-003170-44-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