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Canadian Observation Trial in CF Patients Undergoing Treatment With Ivacaftor

NCT03390985 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2018-01-05

No results posted yet for this study

Summary

Specific aims:

1. To elucidate the biological mechanism that leads to pulmonary and nutritional improvement in CF patients following treatment with ivacaftor using advanced techniques to assess changes of the pulmonary and nutritional status
2. To examine the relation between the individual response to ivacaftor and the presence of modifier genes associated with CF disease severity,
3. To assess altered CFTR function using new available in vivo tests,
4. To validate newly developed in vivo sweat tests with well established functional tests,
5. To establish correlation between the CFTR response to Vx-770 measured in a new ex vivo method (organoids) and the actual clinical and/or functional response in individual patients,
6. To examine response in other CF-specific features such as aqua wrinkling.
7. To examine if sleep/activity level changes.
8. To establish a biorepository to enable further investigations.

Conditions

Sponsors & Collaborators

  • Tanja Gonska

    lead OTHER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-23
Primary Completion
2017-07-26
Completion
2017-07-26

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03390985 on ClinicalTrials.gov