LUMACAFTOR ( DrugBank: Lumacaftor )
1 disease
告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
299 | 嚢胞性線維症 | 82 |
299. 嚢胞性線維症
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
Showing 1 to 10 of 82 diseases
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 |
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1 | NCT04235140 (ClinicalTrials.gov) | February 24, 2020 | 15/1/2020 | Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F50 ... | A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumac ... | Cystic Fibrosis | Drug: LUM/IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Months | N/A | All | 52 | Phase 3 | United States;Canada |
2 | EUCTR2019-001314-41-NL (EUCTR) | 06/05/2019 | 06/05/2019 | This study investigates the effect of switching from Orkambi treatment to Symkevi. In particuar we want to investigate the effect of the switch on the uptake, concentration in the blood an degradation of ivacaftor. This study investigates the effect of switching from Orkambi treatment to Symkevi. In particuar we w ... | Kinetics of ivacaftor at Switch Orkambi Symkevi study - SOS | Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and A ... | Trade Name: Orkambi: contains lumacaftor and ivacaftor Product Name: Orkambi Trade Name: Symkevi Product Name: Symkevi Trade Name: Kalydeco Product Name: Kalydeco Trade Name: Orkambi: contains lumacaftorand ivacaftor Product Name: Orkambi Trade Name: Symkevi Product ... | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Netherlands | |||
3 | NCT03956589 (ClinicalTrials.gov) | October 1, 2018 | 2/5/2019 | Functional Respiratory Imaging and Orkambi in CF | Functional Respiratory Imaging (FRI) to Assess the Short-term Effect of the Product ORKAMBI (Lumacaftor/ Ivacaftor) on Lung Function in ORKAMBInaive Patients With Cystic Fibrosis Homozygous for Phe508del Functional Respiratory Imaging (FRI) to Assess the Short-term Effect of the Product ORKAMBI (Lumacaf ... | Cystic Fibrosis | Drug: Orkambi | University Hospital, Antwerp | NULL | Terminated | 12 Years | N/A | All | 12 | Phase 4 | Belgium |
4 | NCT03601637 (ClinicalTrials.gov) | September 7, 2018 | 18/7/2018 | Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of A ... | A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaf ... | Cystic Fibrosis | Drug: LUM;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Months | 23 Months | All | 61 | Phase 3 | United States;Canada |
5 | NCT03625466 (ClinicalTrials.gov) | August 10, 2018 | 7/8/2018 | A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Thro ... | An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, ... | Cystic Fibrosis | Drug: LUM;Drug: IVA;Drug: Matched Placebos | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 2 Years | 5 Years | All | 51 | Phase 2 | Germany |
6 | NCT04732910 (ClinicalTrials.gov) | July 1, 2018 | 25/1/2021 | Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulators Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR ... | CFTR Biomarker Studie Bei Patient*Innen Mit Mukoviszidose Und CFTR-Modulatortherapie | Cystic Fibrosis | Drug: Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor-Ivacaftor, Tezacaftor-Ivacaftor, Elexacaftor-Tezacaftor-Ivacaftor Drug: Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor ... | Charite University, Berlin, Germany | Hannover Medical School;Heidelberg University;University of Giessen | Recruiting | 6 Months | N/A | All | 90 | Germany | |
7 | NCT03565692 (ClinicalTrials.gov) | July 1, 2018 | 31/5/2018 | Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-Ivacaftor Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taki ... | Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-Ivacaftor Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taki ... | Cystic Fibrosis | Biological: the lung mycobiota and microbiota profile;Biological: the gut mycobiota and microbiota profile Biological: the lung mycobiota and microbiota profile;Biological: the gut mycobiota and microbiota p ... | University Hospital, Bordeaux | Societe Francaise de la Mucoviscidose | Recruiting | 2 Years | N/A | All | 250 | France | |
8 | EUCTR2017-003761-99-DE (EUCTR) | 27/06/2018 | 19/02/2018 | A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Y ... | An Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del An Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Orkambi 100 mg/125 mg film-coated tablets Product Name: LUM/IVA fixed-dose combination INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR Product Name: lumacaftor/ ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other ... | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Germany | ||
9 | EUCTR2018-001573-24-BE (EUCTR) | 11/06/2018 | 08/05/2018 | Evaluation of the short-term effect of ORKAMBI on lung function in patients with cystic fibrosis who have two copies of the F508del mutation using functional respiratory imaging Evaluation of the short-term effect of ORKAMBI on lung function in patients with cystic fibrosis who ... | Functional Respiratory Imaging (FRI) to assess the short-term effect of the product ORKAMBI (lumacaftor/ ivacaftor) on lung function in ORKAMBI-naive patients with Cystic Fibrosis Homozygous for Phe508del. Functional Respiratory Imaging (FRI) to assess the short-term effect of the product ORKAMBI (lumacaf ... | Cystic Fibrosis Homozygous (homozygous for the F508del mutation) 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Cystic Fibrosis Homozygous (homozygous for the F508del mutation) MedDRA version: 20.0;Level: PT;Clas ... | Trade Name: Orkambi INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Orkambi INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed ... | Antwerp University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Belgium | ||
10 | 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. A Study of the Effect of Combination Lumacaftorand Ivacaftor on Glucose Tolerance in Persons With Cy ... | Diabetes;Cystic Fibrosis | Drug: Lumacaftor-ivacaftor;Other: OGTT | Massachusetts General Hospital | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | N/A | NULL |