Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Cystic Fibrosis
Спонсор: Vertex Pharmaceuticals Incorporated
Налично на:
БГ
Обобщение
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).
Кой може да участва
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.
Места на провеждане
9
Австралия (1)
The Kids Research Institute Australia
Nedlands
Канада (1)
Hospital for Sick Children - Pulmonology
Toronto
Франция (1)
Hopital Femme Mere-Enfant
Bron
Германия (1)
Charite Paediatric Pulmonology Department
Berlin
Нидерландия (1)
Sophia Children's Hospital
Rotterdam
New Zealand (1)
Starship Child Health
Grafton
Швеция (1)
Sahlgrenska Universitetssjukhuset - Göteborg CF-center