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By invitation only Phase 3 NCT05844449

Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year 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 this study is to evaluate the long-term safety, tolerability, and efficacy of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis (CF).
Who can participate
Key Inclusion Criteria: Parts A and B: • Participants who have completed study drug treatment in the parent study (VX21-121-105; NCT Number: NCT05422222) Part B: -Meets at least 1 of the following criteria: * Completed study drug treatment in Part A * Had study drug interruption(s) in Part A, but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the treatment period of Part A Key Exclusion Criteria: * Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe hepatic impairment that might pose an additional risk in administering study drug * History of solid organ, hematological transplantation, or cancer * History of drug intolerance in the parent study Other protocol defined Inclusion/Exclusion criteria may apply.
Locations 9
Australia (1)
The Kids Research Institute Australia
Nedlands
Canada (1)
Hospital for Sick Children - Pulmonology
Toronto
France (1)
Hopital Femme Mere-Enfant
Bron
Germany (1)
Charite Paediatric Pulmonology Department
Berlin
Netherlands (1)
Sophia Children's Hospital
Rotterdam
New Zealand (1)
Starship Child Health
Grafton
Sweden (1)
Sahlgrenska Universitetssjukhuset - Göteborg CF-center
Gothenburg
United Kingdom (1)
Noah's Ark Children's Hospital for Wales
Cardiff
United States (1)
Children's Hospital of Orange County
Orange , California
Technical details
Status
By invitation only
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Healthy volunteers
No
Start date
11.08.2023
Completion date
30.07.2029
Registry ID
NCT05844449
Source
anzctr
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