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

61 trials found

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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	NCT04235140 (ClinicalTrials.gov)	February 24, 2020	15/1/2020	Long-term Safety of Lumacaftor/Ivacaftorin Subjects With Cystic Fibrosis Who Are Homozygous for F508 ...	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	NCT03601637 (ClinicalTrials.gov)	September 7, 2018	18/7/2018	Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftorin Participants 1 to Less Than 2 Years of Ag ...	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
3	NCT03625466 (ClinicalTrials.gov)	August 10, 2018	7/8/2018	A Study to Explore the Impact of Lumacaftor/Ivacaftoron Disease Progression in Subjects Aged 2 Throu ...	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
4	EUCTR2017-003761-99-DE (EUCTR)	27/06/2018	19/02/2018	A Study of the Effects of Lumacaftor/Ivacaftoron Disease Progression in Subjects Aged 2 Through 5 Ye ...	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;Sy ...	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
5	NCT03150719 (ClinicalTrials.gov)	May 24, 2017	3/5/2017	A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) ...	Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, E ...	Cystic Fibrosis	Drug: Tezacaftor /Ivacaftor;Drug: Ivacaftor;Drug: Placebo	Vertex Pharmaceuticals Incorporated	NULL	Completed	12 Years	N/A	All	98	Phase 3	United States;France;Germany
6	NCT03125395 (ClinicalTrials.gov)	May 12, 2017	19/4/2017	A Rollover Safety Study of Lumacaftor/Ivacaftorin Subjects Aged 2 Years and Older With Cystic Fibros ...	A Phase 3, Rollover Study to Evaluate the Safety of Long-term Treatment With Lumacaftor/IvacaftorCom ...	Cystic Fibrosis	Drug: LUM/IVA	Vertex Pharmaceuticals Incorporated	NULL	Completed	2 Years	N/A	All	57	Phase 3	United States;Canada
7	EUCTR2016-004996-33-ES (EUCTR)	03/05/2017	10/03/2017	A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/IvacaftorAdher ...	A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adher ...	Cystic fibrosis subjects Homozygous for the F508del-CFTR Mutation MedDRA version: 19.1;Level: SOC;Cl ...	Trade Name: Orkambi Product Name: Orkambi INN or Proposed INN: Lumacaftor Other descriptive name: LUMAC ...	Vertex Pharmaceuticals Incoporated	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 4	United States;Canada;Spain;Australia;United Kingdom
8	NCT03061331 (ClinicalTrials.gov)	January 31, 2017	9/2/2017	Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of ...	Cystic Fibrosis	Drug: LUM/IVA;Drug: Placebo	Vertex Pharmaceuticals Incorporated	NULL	Completed	12 Years	N/A	All	20	Phase 2	Netherlands
9	EUCTR2015-004841-13-CZ (EUCTR)	04/01/2017	10/08/2016	A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homoz ...	A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evalu ...	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ...	Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: ...	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	France;United States;Czech Republic;Ireland;United Kingdom
10	NCT04623879 (ClinicalTrials.gov)	December 29, 2016	12/10/2020	Real Life Evaluation of the Multi-organ Effects of Lumacaftor/Ivacaftoron F508del Homozygous Cystic ...	Real Life Evaluation of the Multi-organ Effects of Lumacaftor/Ivacaftoron F508del Homozygous Cystic ...	Cystic Fibrosis	Drug: Lumacaftor , Ivacaftor Drug Combination	Carmel Medical Center	NULL	Completed	18 Years	99 Years	All	13		NULL

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