Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)
NCT ID: NCT02445053
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
75 participants
OBSERVATIONAL
2015-04-30
2020-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ivacaftor
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 1 allele with 1 of the following CFTR mutations: G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D
* Six years of age or older on the date of signed (Informed Consent Form) ICF, and where appropriate, date of assent
* Signed ICFs and, where appropriate, signed Assent Form
* Able to understand the study requirements and comply with study data collection procedures
Exclusion Criteria
* Currently enrolled in a Kalydeco interventional study or other interventional therapeutic clinical study directed at CFTR modulation
* History of organ transplantation
6 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bari, , Italy
Messina, , Italy
Milan, , Italy
Milan, , Italy
Naples, , Italy
Potenza, , Italy
Verona, , Italy
The Hague, South Holland, Netherlands
Amsterdam, , Netherlands
Gronningen, , Netherlands
Heidelberglaan, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
London, Greater London, United Kingdom
Birmingham, West Midlands, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-002704-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX14-770-116
Identifier Type: -
Identifier Source: org_study_id