SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02194881

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation - Efficacy and Safety Results After the First Year of Treatment in the Real Life Setting.

The purpose of this study is to determine whether the treatment with Ivacaftor remains effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR mutation) in the real life setting, after the drug has been approved by the Health authorities.

NCT02194881 Cystic Fibrosis
MeSH: Fibrosis Cystic Fibrosis

1 Interventions

Name: CF patients with a G551D mutation and treated with Ivacaftor

Type: Drug

Ivacaftor 1


Primary Outcomes

Description: pulmonary function

Measure: FEV1 (in liters and in % predicted)

Time: until one years after initiation of treatment

Secondary Outcomes

Measure: pulmonary exacerbations

Time: until one years after initiation of treatment

Measure: number of hospitalizations and number of days of hospitalization per year

Time: until one year after initiation of treatment

Description: number of oral antibiotic treatments and number of days of oral antibiotic treatments, number of IV courses and days of IV antibiotics per year

Measure: number of antibiotic treatments and number of days of antibiotic treatments

Time: until one year after initiation of treatment

Description: Evolution of bacteria and fungi in sputum

Measure: respiratory colonization

Time: until least one year after initiation of treatment

Description: Weight (and BMI-Zscore for children)

Measure: nutritional status

Time: until one year after initiation of treatment

Description: Dates and reasons for interruption and discontinuation of treatment with Ivacaftor Adverse events, indicating what in the physician's opinion might be due to Ivacaftor

Measure: Adverse events

Time: until one year after initiation of treatment

Time Perspective: Retrospective

Cohort


There is one SNP

SNPs


1 G551D

Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation - Efficacy and Safety Results After the First Year of Treatment in the Real Life Setting.. Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation The purpose of this study is to determine whether the treatment with Ivacaftor remains effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR mutation) in the real life setting, after the drug has been approved by the Health authorities. --- G551D ---

Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation - Efficacy and Safety Results After the First Year of Treatment in the Real Life Setting.. Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation The purpose of this study is to determine whether the treatment with Ivacaftor remains effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR mutation) in the real life setting, after the drug has been approved by the Health authorities. --- G551D --- --- G551D ---

Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation - Efficacy and Safety Results After the First Year of Treatment in the Real Life Setting.. Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation The purpose of this study is to determine whether the treatment with Ivacaftor remains effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR mutation) in the real life setting, after the drug has been approved by the Health authorities. --- G551D --- --- G551D --- --- G551D ---

Inclusion Criteria: - French patients with CF aged 6 or older who are homozygous or heterozygous for the G551D mutation - Treated with Ivacaftor - First prescription of Ivacaftor before June 1st 2013 (including patients randomized in the VX770 clinical trials) Exclusion Criteria: - CF patients younger than 6 years old - CF patients who have received lung transplantation - CF patients without a G551D mutation. --- G551D ---

Inclusion Criteria: - French patients with CF aged 6 or older who are homozygous or heterozygous for the G551D mutation - Treated with Ivacaftor - First prescription of Ivacaftor before June 1st 2013 (including patients randomized in the VX770 clinical trials) Exclusion Criteria: - CF patients younger than 6 years old - CF patients who have received lung transplantation - CF patients without a G551D mutation. --- G551D --- --- G551D ---



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