Cystic Fibrosis MedDRA version: 12.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Conditions
Interventions
Product Name: VX-770
Product Code: VX-770, VRT-8130077
Pharmaceutical Form: Tablet
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Other descriptive name: VRT-813077
Concentration unit: mg millig
Sponsors
Vertex Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects who have completed the assigned study treatment Study 102 or Study 103 who meet certain criteria. - Subjects who are females of childbearing potential must have a negative urine pregnancy test on Day 1 (first dose of VX-770). - Subjects who are able to understand and comply with protocol requirements, restrictions, and instructions and likely to complete the study as planned, as judged by the investigator. - Subjects of child bearing potential and who are sexually active must meet the contraception requirements. - Subjects must sign the informed consent form (ICF), and where appropriate, assent must be obtained. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects with a history of any illness or condition 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. - Subjects with a history of study treatment intolerance as observed in their previous VX 770 study that, in the opinion of the investigator, might pose an additional risk in administering study drug to the subject. - Subjects who are pregnant, planning a pregnancy, breast-feeding, or not willing to follow contraception requirements. - Subjects taking any inhibitors or inducers of CYP3A4, including certain herbal medications (e.g., St. John’s Wort) and grapefruit/grapefruit juice.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of long-term VX-770 treatment in subjects with cystic fibrosis (CF) ;Secondary Objective: To evaluate the efficacy of long-term VX-770 treatment in subjects with CF ;Primary end point(s): Safety as determined by adverse events, clinical laboratory values (serum chemistry, hematology, coagulation studies, and urinalysis), standard digital ECGs, vital signs, and physical examinations | — |
Countries
Czech Republic, France, Germany, Ireland, United Kingdom
Outcome results
None listed