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Drug & research development » Clinical trials » NCT02194881

Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation (IVACAFTOR1)

Official title: 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.

Clinical Trials gov number: NCT02194881

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Purpose: To determine whether treatment with ivacaftor remains effective and safe in CF patients (with at least one G551D CFTR mutation) after the drug has been approved by health authorities.

Phase: NA

Type: Observational, retrospective, cohort

Study sponsor: Assistance Publique – Hospitaux de Paris; Vaincre la Mucoviscidose

  • French patients with CF who are homozygous or heterozygous for the G551D mutation
  • Treated with ivacaftor
  • First prescription of ivacaftor before 1 June 2013 (including patients randomised in the VX770 clinical trials)

Intervention
Ivacaftor

Geographical Location
France

Number of Participants
51-100 (≥6 years)

Primary Endpoint

FEV1 (in liters and in % predicted) at 1 year after treatment initiation

Secondary Endpoint

At 1 year after treatment initiation:

  • Pulmonary exacerbations
  • Number of hospitalizations and days of hospitalization per year
  • Number of antibiotic treatments and days of antibiotic treatments
  • Respiratory colonization
  • Nutritional status
  • Adverse events

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Not provided

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