Cystic Fibrosis MedDRA version: 20.0 Level: SOC Classification code 10010331 Term: Congenital, familial and genetic disorders System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Product Name: 100-mg VX-445 /50-mg TEZ/75-mg
Product Code: VX-445 /TEZ/IVA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TEZACAFTOR
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Sponsors
Vertex Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subject (or his or her legally appointed and authorized representative) is willing to sign and date an informed consent form (ICF), and, when appropriate, an assent form. 2.Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures. 3.Currently participating in Study 659-105. Current participation is defined as one of the following: •On study drug treatment in Study 659-105 as of the day prior to the Day 1 Visit in this study. •On study drug interruption in Study 659-105 as of the day prior to the Day 1 Visit in this study. Subjects who permanently discontinue VX-659/TEZ/IVA in Study 659-105 for any reason other than enrolling into this study are not eligible. 4.Willing to remain on a stable CF treatment regimen (as defined in Section 9.5) through completion of study participation Are the trial subjects under 18? yes Number of subjects for this age range: 139 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 366 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1.History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. 2.Pregnant and nursing females. All female subjects must have a negative pregnancy test at the Day 1 Visit before receiving the first dose of study drug. 3.History of drug intolerance in Study 659-105 that would pose an additional risk to the subject in the opinion of the investigator (e.g., subjects with a history of allergy or hypersensitivity to VX-659/TEZ/IVA). 4.Current participation in an investigational drug trial (other than Study 659 105). Participation in a non-interventional study (including observational studies, registry studies, and studies requiring blood collections without administration of study drug) and screening for another Vertex study is permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of VX-445/tezacaftor (TEZ)/ivacaftor (IVA);Secondary Objective: not applicable ;Primary end point(s): Safety and tolerability of long-term treatment with VX-445/TEZ/IVA based on adverse events (AEs), clinical laboratory values, ECGs, vital signs, pulse oximetry, and spirometry.;Timepoint(s) of evaluation of this end point: assessed throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none | — |
Countries
Australia, Canada, Denmark, Germany, Ireland, Israel, Poland, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Trials and Medical Info
Vertex Pharmaceuticals Incorporated
Outcome results
None listed