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Active (not recruiting) Phase 3 NCT06460506

Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older

Phase 3 – large-scale trial before approval
Conditions: Cystic Fibrosis

Sponsor: Vertex Pharmaceuticals Incorporated

trial.available_in: БГ
Overview
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
Who can participate
Key Inclusion Criteria: * Completed study drug treatment in the parent study VX22-445-122 Part B (NCT05882357) OR had study drug interruption(s) in the parent study but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the Treatment Period of the parent study Key Exclusion Criteria: * History of drug intolerance in the parent study that would pose an additional risk to the participant * Current participation in an investigational drug trial other than the parent study Other protocol defined Inclusion/Exclusion criteria may apply.
Locations 6
Australia (1)
The Kids Research Institute Australia
Nedlands
Canada (1)
The Hospital for Sick Children
Toronto
Denmark (1)
Juliane Marie Center, Rigshospitalet
Copenhagen
Netherlands (1)
Erasmus Medical Center
Rotterdam
Switzerland (1)
Inselspital - Universitaetsspital Bern
Bern
United Kingdom (1)
Children and Young Adults Research Unit
Cardiff
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Months
Healthy volunteers
No
Start date
21.11.2024
Completion date
30.09.2027
Registry ID
NCT06460506
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.