VX-121/TEZ/D-IVA
DrugFixed-dose combination tablets for oral administration.
Other names: VX-121/VX-661/CTP-656, VX-121/VX-661/VX-561, VX-121/tezacaftor/deutivacaftor
NCT Number: NCT05076149
The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.
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Notify Me12 year and older
All sexes
Interventional
Phase 3
Royal Prince Alfred Hospital, Camperdown, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Fixed-dose combination tablets for oral administration.
Other names: VX-121/VX-661/CTP-656, VX-121/VX-661/VX-561, VX-121/tezacaftor/deutivacaftor
Fixed-dose combination tablets for oral administration.
Other names: VX-445/VX-661/VX-770, elexacaftor/tezacaftor/ivacaftor
Tablet for oral administration.
Other names: VX-770, ivacaftor
Placebo matched to VX-121/TEZ/D-IVA for oral administration.
Placebo matched to ELX/TEZ/IVA for oral administration.
Placebo matched to IVA for oral administration.
Time frame: From Baseline Through Week 24
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Time frame: From Baseline Through Week 24
Sweat samples were collected using an approved collection device.
Time frame: From Baseline Through Week 24
Sweat samples were collected using an approved collection device.
Time frame: From Baseline Through Week 24
Sweat samples were collected using an approved collection device.
Vertex Pharmaceuticals Incorporated
Industry
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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