https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-000185-11/SE/

Controlled: No.1 Randomised: No.2 Open: Yes.3 Single blind: No.4 Double blind: No.5 Parallel group: No.6 Cross over: No

Principal inclusion criteria: 1. Subject (or his or her legally appointed and authorized representative) will 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. Did not withdraw consent from a parent study.4. Meets at least 1 of the following criteria:Completed study drug treatment in a parent study.Had study drug interruption(s) in a parent study, but completed study visits up to the last scheduled visit of the Treatment Period of a parent study.5. Willing to remain on a stable CF treatment regimen (as defined in Section 9.5) through completion of study participation.2. Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.3. Did not withdraw consent from a parent study.4. Meets at least 1 of the following criteria:Completed study drug treatment in a parent study.Had study drug interruption(s) in a parent study, but completed study visits up to the last scheduled visit of the Treatment Period of a parent study.5. Willing to remain on a stable CF treatment regimen (as defined in Section 9.5) through completion of study participation.

Main objective of the trial: To evaluate the long-term safety and tolerability of VX-445 in TC with TEZ and IVA in subjects with CF who are homozygous or heterozygous for the F508del mutation

Primary end point(s): Safety and tolerability of long-term treatment with VX-445 in TC with TEZ and IVA based on adverse events (AEs), clinical laboratory values, ECGs, vital signs, and pulse oximetry.