Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
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 pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Кой може да участва
Key Inclusion Criteria:
* Participants with stable CF and at least 1 TCR mutation (including F508del) in the CFTR gene
Key Exclusion Criteria:
* History of solid organ, hematological transplantation, or cancer
* Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
* Lung infection with organisms associated with a more rapid decline in pulmonary status
Other protocol defined Inclusion/Exclusion criteria may apply.
Места на провеждане
9
Австралия (1)
The Kids Research Institute Australia
Nedlands
NOT_YET_RECRUITING
Канада (1)
The Hospital for Sick Children
Toronto
NOT_YET_RECRUITING
Франция (1)
CHU Lyon - Hopital Femme Mere-Enfant
Bron
NOT_YET_RECRUITING
Германия (1)
Charité - Paediatric Pulmonology Department
Berlin
NOT_YET_RECRUITING
Нидерландия (1)
Erasmus Medical Center / Sophia Children's Hospital