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 | NCT04731272 (ClinicalTrials.gov) | April 20, 2021 | 26/1/2021 | GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance | Effect 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 Trial | Cystic Fibrosis;Pancreatic Insufficiency;Abnormal Glucose Tolerance;Diabetes | Drug: Dulaglutide 0.75Mg/0.5Ml Inj Pen | University of Pennsylvania | Children's Hospital of Philadelphia | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 2 | NCT04533646 (ClinicalTrials.gov) | March 17, 2021 | 23/8/2020 | Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes | Comparison of Meal-Time Dosing of Rapid Acting Insulin Using Carbohydrate Counting vs. Fixed Doses Utilizing Continuous Glucose Monitoring In Patients With Cystic Fibrosis Related Diabetes | Cystic Fibrosis-related Diabetes | Drug: Insulin;Device: Continuous glucose monitor (CGM) | Jagdeesh Ullal | Wake Forest University Health Sciences | Recruiting | 18 Years | 80 Years | All | 20 | Phase 4 | United States |
| 3 | NCT04579939 (ClinicalTrials.gov) | February 25, 2021 | 29/9/2020 | Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis | Oral Glucose Tolerance Testing Using Candy: A Sweet Solution to Improve Screening Compliance in Cystic Fibrosis | Cystic Fibrosis | Diagnostic Test: Candy Glucose Tolerance Test | Mayo Clinic | NULL | Recruiting | 10 Years | 21 Years | All | 10 | N/A | United States |
| 4 | NCT04599465 (ClinicalTrials.gov) | January 18, 2021 | 21/10/2020 | A 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 Metabolism | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Years | N/A | All | 69 | Phase 3 | Spain;Netherlands;Italy;France;Czechia;Belgium;Australia |
| 5 | EUCTR2020-003170-44-IT (EUCTR) | 14/12/2020 | 15/06/2021 | NA | A 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 INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Czechia;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy | ||
| 6 | EUCTR2020-003170-44-CZ (EUCTR) | 03/12/2020 | 22/10/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Czechia;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy | ||
| 7 | NCT03650712 (ClinicalTrials.gov) | July 1, 2019 | 18/7/2018 | EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis | EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis | Cystic Fibrosis-related Diabetes | Diagnostic Test: Oral glucose tolerance test;Diagnostic Test: Continuous glucose monitoring;Diagnostic Test: Dexa scan | Katie Larson Ode | NULL | Active, not recruiting | 6 Years | N/A | All | 404 | N/A | United States |
| 8 | NCT03961516 (ClinicalTrials.gov) | May 1, 2019 | 16/5/2019 | Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis | Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis | Cystic Fibrosis;Cystic Fibrosis-related Diabetes;Cystic Fibrosis Liver Disease;Pancreatic Steatosis;Hepatic Steatosis | Device: Frequently Sampled Oral Glucose Tolerance Test and CGM;Radiation: MRI Pancreas and Liver | University Hospitals Cleveland Medical Center | NULL | Active, not recruiting | 6 Years | 40 Years | All | 40 | United States | |
| 9 | NCT02653027 (ClinicalTrials.gov) | January 1, 2018 | 7/1/2016 | Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508del | A 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 Fibrosis | Drug: Lumacaftor-ivacaftor;Other: OGTT | Massachusetts General Hospital | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | N/A | NULL |
| 10 | NCT02955888 (ClinicalTrials.gov) | January 3, 2017 | 21/10/2016 | Study of Safety, Tolerability & Efficacy in Cystic Fibrosis Patients With Abnormal Glucose Tolerance | A 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 Tolerance | Cystic Fibrosis | Drug: PBI4050;Drug: Placebo | Liminal BioSciences Ltd. | NULL | Terminated | 18 Years | N/A | All | 11 | Phase 2 | Canada |
| 11 | NCT03512119 (ClinicalTrials.gov) | February 11, 2016 | 15/1/2018 | Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor | Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor | Cystic Fibrosis Homozygous for Phe 508 Del CFTR;Glucose Intolerance or Newly Diagnosis Diabetes | Drug: Lumacaftor-Ivacaftor treatment | University Hospital, Strasbourg, France | NULL | Completed | 12 Years | N/A | All | 55 | France | |
| 12 | NCT02703155 (ClinicalTrials.gov) | October 2015 | 9/2/2016 | The Use of Home Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes | The Use of Self-Administered Electronic Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes in Children With Cystic Fibrosis | Cystic Fibrosis Related Diabetes;Cystic Fibrosis | Device: Home Oral Glucose Tolerance Test kit | Great Ormond Street Hospital for Children NHS Foundation Trust | University College, London | Recruiting | 10 Years | 17 Years | Both | 30 | N/A | United Kingdom |
| 13 | NCT02569229 (ClinicalTrials.gov) | June 2015 | 12/8/2015 | Glucose Tolerance in Children With Cystic Fibrosis | Glucose Tolerance and Its Clinical Impact in Children and Adolescents With Cystic Fibrosis | Glucose Intolerance;Cystic Fibrosis | Other: Diagnostics for glucose tolerance with 3 different methods. | Christoph Saner | University Hospital Inselspital, Berne | Active, not recruiting | 10 Years | 20 Years | All | 14 | Switzerland | |
| 14 | NCT02398383 (ClinicalTrials.gov) | March 2015 | 22/1/2015 | Role of Glucagon In Glucose Control in Cystic Fibrosis Related Diabetes | Role of Glucagon in Glucose Control in Cystic Fibrosis Related Diabetes | Cystic Fibrosis;Cystic Fibrosis Related Diabetes | Other: Oral Glucose Tolerance Test;Other: Mixed Meal Tolerance Test;Other: Hypoglycemic Clamp | Yale University | NULL | Completed | 12 Years | 45 Years | All | 7 | Early Phase 1 | United States |
| 15 | NCT02202876 (ClinicalTrials.gov) | November 2014 | 25/7/2014 | Redox Imbalance and the Development of Cystic Fibrosis Diabetes | Redox Imbalance and the Development of Cystic Fibrosis Diabetes | Diabetes Mellitus, Type 2;Cystic Fibrosis | Other: Oral Glucose Tolerance Test;Other: High Glycemic Index Meal;Other: Low Glycemic Index Meal;Other: Test Soda;Other: Fruit juice | Emory University | Cystic Fibrosis Foundation | Completed | 1 Year | N/A | All | 34 | N/A | United States |
| 16 | NCT01975259 (ClinicalTrials.gov) | December 2013 | 11/9/2013 | Investigating the Incretin Effect in Cystic Fibrosis | Investigating the Incretin Effect in Cystic Fibrosis | Cystic Fibrosis | Drug: 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 Monitoring | Liverpool Heart and Chest Hospital NHS Foundation Trust | NULL | Completed | 17 Years | 50 Years | Both | 50 | N/A | United Kingdom |
| 17 | NCT01883037 (ClinicalTrials.gov) | June 2013 | 13/6/2013 | Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RT | To Compare the Clinical Accuracy of Glucose Measurement During Oral Glucose Tolerance Test Using Two Methods: i) Laboratory Standard Technique, ii) HemoCue Glucose 201 RT System | Cystic Fibrosis | Other: Blood glucose results | Royal Brompton & Harefield NHS Foundation Trust | NULL | Completed | 16 Years | N/A | Both | 70 | N/A | United Kingdom |
| 18 | NCT01852448 (ClinicalTrials.gov) | May 2013 | 9/5/2013 | Genetics of Insulin and Incretins in Cystic Fibrosis | Evaluation of the Enteroinsular Axis in Cystic Fibrosis | Cystic Fibrosis | Genetic: Blood or Saliva Sample Collection;Other: Glucose -potentiated arginine (GPA) stimulation tests | Children's Hospital of Philadelphia | University of Pennsylvania | Active, not recruiting | 2 Years | N/A | All | 550 | United States | |
| 19 | EUCTR2011-002719-27-IT (EUCTR) | 30/12/2011 | 13/03/2012 | EFFECT OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I ON GLUCOSE TOLERANCE AND AS PREVENTION TOWARDS THE DEVELOPMENT OF CYSTIC FIBROSIS RELATED DIABETES MELLITUS | GLUCOSE 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 PARMA | NULL | Not Recruiting | Female: yes Male: yes | 20 | Italy | |||
| 20 | NCT03644199 (ClinicalTrials.gov) | March 30, 2011 | 10/5/2016 | Development of Diabetes in Adults With Cystic Fibrosis (CF) | Factors Responsible for the Development of Diabetes in Adults With Cystic Fibrosis | Cystic Fibrosis | Other: Oral Glucose Tolerance Test (OGTT) assessment arm;Other: Mixed meal test evaluation test arm | Liverpool Heart and Chest Hospital NHS Foundation Trust | NULL | Withdrawn | 18 Years | 50 Years | All | 0 | N/A | United Kingdom |
| 21 | NCT01149005 (ClinicalTrials.gov) | June 2010 | 9/6/2010 | Cystic Fibrosis (CF) Exacerbation and Insulin Treatment | Evaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation | Cystic Fibrosis;Impaired Glucose Tolerance;Pulmonary Exacerbation | Drug: novorapid / humalog short acting insulin;Drug: Novo Rapid Insulin (Novonordisk) | Hadassah Medical Organization | NULL | Not yet recruiting | 10 Years | N/A | Both | 30 | N/A | Israel |
| 22 | NCT00967798 (ClinicalTrials.gov) | May 2010 | 27/8/2009 | Prevention of Cystic Fibrosis Diabetes | A 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 Diabetes | Cystic Fibrosis;Prediabetes | Drug: Sitagliptin | Emory University | NULL | Terminated | 13 Years | N/A | All | 33 | Phase 3 | United States;Canada |
| 23 | NCT02723968 (ClinicalTrials.gov) | September 2009 | 21/3/2016 | Cystic Fibrosis Related Diabetes Screening. | Sensitivity and Specificity of Different Methods for Cystic Fibrosis-related Diabetes Screening. | Cystic Fibrosis-related Diabetes | Other: 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 test | Hospices Civils de Lyon | NULL | Completed | 10 Years | 18 Years | All | 29 | N/A | NULL |
| 24 | NCT01091025 (ClinicalTrials.gov) | March 2009 | 18/3/2010 | Comparing Two Different Approaches in the Screening of Cystic Fibrosis Related Diabetes | A 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 Test | Screening of Cystic Fibrosis Related Diabetes | Other: Glucose profile for 2 weeks | Imperial College London | Royal Brompton & Harefield NHS Foundation Trust | Completed | 16 Years | N/A | All | 100 | N/A | United Kingdom |
| 25 | EUCTR2007-004956-35-GB (EUCTR) | 27/08/2008 | 26/11/2007 | The 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 | The 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 London | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 26 | NCT00476281 (ClinicalTrials.gov) | April 2008 | 18/5/2007 | Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis | Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis | Cystic Fibrosis;Diabetes | Procedure: Urinary collect;Procedure: Continuous Glucose Monitoring System (CGMS) | University Hospital, Strasbourg, France | Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine | Completed | 10 Years | N/A | All | 114 | N/A | France |
| 27 | EUCTR2005-002997-31-GB (EUCTR) | 10/08/2006 | 09/11/2005 | A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes | A 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 Penfill | Sheffield Children's NHS Trust | NULL | Not 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): yes | United Kingdom | ||
| 28 | NCT00287456 (ClinicalTrials.gov) | February 2, 2006 | 2/2/2006 | Use of the Insulin Pump in Cystic Fibrosis Patients With Impaired Glucose Tolerance or CFRD and in Type 1 Diabetes Patients. | Cystic Fibrosis Related Diabetes | Device: Insulin Pump;Drug: Insulin;Procedure: Oral Glucose Tolerance Test;Procedure: Whole body Protein Turnover | University of Texas Southwestern Medical Center | NULL | Withdrawn | 12 Years | 32 Years | All | 0 | N/A | United States | |
| 29 | NCT00287443 (ClinicalTrials.gov) | February 2, 2006 | 2/2/2006 | Metabolic Abnormalities in Hispanic Children With Cystic Fibrosis | Cystic Fibrosis | Procedure: 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 Test | University of Texas Southwestern Medical Center | Genentech, Inc. | Withdrawn | 7 Years | 17 Years | All | 0 | N/A | United States | |
| 30 | NCT00483769 (ClinicalTrials.gov) | February 2006 | 6/6/2007 | One Year Glargine Treatment in CFRD Children and Adolescents | One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements | Cystic Fibrosis;Glucose Metabolism Disorders | Drug: Glargine | Federico II University | NULL | Completed | 3 Years | 20 Years | Both | 20 | Phase 4 | Italy |
| 31 | EUCTR2005-002135-27-IT (EUCTR) | 06/07/2005 | 28/06/2005 | Glargine insulin efficacy in Cystic Fibrosis patients with glucose intolerance and clinical deterioration | Glargine 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 GASLINI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 32 | EUCTR2004-005019-28-GB (EUCTR) | 09/05/2005 | 19/04/2005 | Diabetes therapy to improve body mass index pulmoanry function in cystic fibrosis subjects with abnormal blood glucose | Diabetes therapy to improve body mass index pulmoanry function in cystic fibrosis subjects with abnormal blood glucose | Cystic fibrosis related diabetes mellitus | Trade Name: NovoRapid Aspartate INN or Proposed INN: Novo Rapid Trade Name: Rapeglinide INN or Proposed INN: Rapeglinide | Papworth Hospital NHS Foundation Trust | NULL | Not 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): yes | United Kingdom | ||
| 33 | NCT00014768 (ClinicalTrials.gov) | February 2001 | 10/4/2001 | Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis | Cystic Fibrosis | Drug: glucose;Drug: insulin;Drug: leucine | National Center for Research Resources (NCRR) | University of Utah | Terminated | N/A | N/A | Female | 36 | N/A | United States | |
| 34 | EUCTR2020-003170-44-BE (EUCTR) | 16/10/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A 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 Incorporated | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy | |||
| 35 | EUCTR2020-003170-44-NL (EUCTR) | 09/11/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A 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 Incorporated | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Czechia;Spain;Belgium;Australia;Netherlands;Italy | |||
| 36 | EUCTR2020-003170-44-FR (EUCTR) | 22/10/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A 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 Incorporated | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy |