Conditions: Cystic Fibrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 206
Healthy volunteers: no

Brief summary:
To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation

Detailed description:

Arms:
arm 1: Fixed-dose combination with lumacaftor (LUM) 200 mg every 12 hours (q12h)/ ivacaftor (IVA) 250 mg q12h arm 2: Matching placebo q12h

Interventions: intervention 1: VX-809 intervention 2: Placebo intervention 3: VX-770
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: