Language: BG BG
← Back to results
Recruiting Phase 3 NCT05422222

Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age

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 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.
Who can participate
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.
Locations 9
Australia (1)
The Kids Research Institute Australia
Nedlands
NOT_YET_RECRUITING
Canada (1)
The Hospital for Sick Children
Toronto
NOT_YET_RECRUITING
France (1)
CHU Lyon - Hopital Femme Mere-Enfant
Bron
NOT_YET_RECRUITING
Germany (1)
Charité - Paediatric Pulmonology Department
Berlin
NOT_YET_RECRUITING
Netherlands (1)
Erasmus Medical Center / Sophia Children's Hospital
Rotterdam
NOT_YET_RECRUITING
New Zealand (1)
Starship Children's Hospital
Grafton
COMPLETED
Sweden (1)
Sahlgrenska Universitetssjukhuset
Gothenburg
COMPLETED
United Kingdom (1)
Children and Young Adults Research Unit
Cardiff
NOT_YET_RECRUITING
United States (1)
Children's Hospital of Orange County
Orange , California
COMPLETED
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Maximum age
11 Years
Healthy volunteers
No
Start date
21.06.2022
Completion date
30.06.2030
Registry ID
NCT05422222
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.