Conditions: Cystic Fibrosis
Keywords: CF
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
The objective of this study was to evaluate the safety and efficacy of VX-661in combination with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation

Detailed description:

Arms:
arm 1: Participants received VX-661 50 milligram (mg) tablet plus Ivacaftor (IVA) 150 mg tablet every 12 hours (q12h) for 12 weeks. arm 2: Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks. arm 3: Participants received two VX-661 50 mg tablets once daily (qd) plus IVA 150 mg tablet q12h for 12 weeks. arm 4: Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks. arm 5: Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.

Interventions: intervention 1: VX-661 intervention 2: Ivacaftor intervention 3: Placebo matched to VX-661 intervention 4: Placebo matched to Ivacaftor
Intervention descriptions: intervention 1: Tablet, oral use intervention 2: Film coated tablet, oral use intervention 3: Tablet, oral use intervention 4: Film coated tablet, oral use

Protocol document: