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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 August 2016 |
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Main ID: |
NCT01937325 |
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Date of registration:
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04/09/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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CPET in CF Patients With One G551D Mutation Taking VX770
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Scientific title:
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Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor) |
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Date of first enrolment:
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February 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01937325 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Contacts
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Name:
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John Wilson |
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Address:
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Telephone:
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Email:
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Affiliation:
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Alfred Health and Monash University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All participants will have CF proven based on established criteria (sweat test,
genotype and phenotype).
- All participants will have at least one copy of the G551D mutation.
- All will be able to perform an exercise study and complete study questionnaires and
assessments.
- Age range will be between 16 and 75 years of age.
- Lung function inclusion will be above 25% predicted FEV1.
Exclusion Criteria:
- Participants will not be included if they are unable to complete study assessments or
have had a known adverse reaction to Ivacaftor.
- Female participants will be excluded if found to return a positive pregnancy test at
screening.
- Participants will be excluded if using St. John's Wort or rifampicin (strong CYP3A
inducers).
- Participants with significant liver dysfunction will be excluded (ALT or ALT above 5
times upper limit of normal).
Age minimum:
16 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: placebo
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Drug: ivacaftor
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Primary Outcome(s)
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exercise capacity
[Time Frame: one month, 3 months]
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Secondary Outcome(s)
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Inflammatory profile
[Time Frame: One month, 3 months]
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Secondary ID(s)
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CPET in CF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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