Status:
COMPLETED
Effect of Lumacaftor/Ivacaftor in Children With Cystic Fibrosis Homozygote for F508del on Small Airway Function
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Vertex Pharmaceuticals Incorporated
Marien Hospital Wesel
Conditions:
Cystic Fibrosis in Children
Eligibility:
All Genders
6-18 years
Brief Summary
To obtain prospective real world data of the effect of lumacaftor/ivacaftor or tezacaftor/ ivacaftor on small airway disease in children aged 6-18 years with cystic fibrosis (CF) homozygous for F508de...
Detailed Description
Multi-center observational study. Duration 12 months after the start of lumacaftor/ ivacaftor or tezacaftor/ ivacaftor . To collect these data and to assist in clinical decisions regarding initiation...
Eligibility Criteria
Inclusion
- Children aged 6-18 years
- CF, Homozygote F508del confirmed by DNA analysis
- Considered for start of lumacaftor/ ivacaftor or tezacaftor/ivacaftor
Exclusion
- \- Unable to perform acceptable, repeatable lung function tests
Key Trial Info
Start Date :
November 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04138589
Start Date
November 1 2017
End Date
July 19 2022
Last Update
November 29 2023
Active Locations (2)
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1
Children's Hospital Marien Hospital Wesel
Düsseldorf, Germany
2
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, Netherlands