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