Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 17.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: > 6 years of age Patient has CF as diagnosed by one of the following: -Documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test, or -Two well characterized genetic mutations in the CFTR gene, or -Abnormal nasal potential difference with accompanying symptoms characteristic of CF PA present in expectorated sputum or throat swab culture within 2 months prior to consent Patient must be able to provide written informed consent/assent prior to any study related procedure; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure At high risk for disease progression as defined by one of the following patient populations: FEV1 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements Patients with hypersensitivity to any of the components of the drug product Currently enrolled in another clinical trial Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to provide expanded access to AZLI 75 mg prior to its commercial availability and establishment of reimbursement programs through Provincial Ministries of Health to patients in Canada with CF and PA airway infection who have limited treatment options and are at risk for disease progression.;Secondary Objective: Not applicable.;Primary end point(s): Not applicable: Expanded Access Program;Timepoint(s) of evaluation of this end point: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Canada
Contacts
Public ContactClinical Trials Information
Gilead Sciences International Ltd
Outcome results
None listed