Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief Summary: Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.


Options:
A: Arm Label: Treatment Period 1: LUM/IVA to LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: LUM/IVA | Arm Label: Treatment Period 1: Placebo (PBO) to LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: LUM/IVA | Arm Label: Treatment Period 1: Observational Cohort; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Treatment Period 2: LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: LUM/IVA | Intervention Type: DRUG; Name: LUM/IVA; Assigned to Arm(s): Treatment Period 1: LUM/IVA to LUM/IVA, Treatment Period 1: Placebo (PBO) to LUM/IVA | Intervention Type: DRUG; Name: LUM/IVA; Assigned to Arm(s): Treatment Period 2: LUM/IVA
B: Arm Label: Placebo; Type: OTHER; Interventions: Drug: Placebo | Arm Label: TEZ/IVA; Type: EXPERIMENTAL; Interventions: Drug: TEZ/IVA, Drug: IVA, Drug: Placebo | Arm Label: Ivacaftor; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: Placebo | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Ivacaftor, TEZ/IVA | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Ivacaftor, Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo, TEZ/IVA
C: Arm Label: Cohort 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Lumacaftor Placebo, Drug: Ivacaftor Placebo | Arm Label: Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 2 and 3: Placebo (HO and HE); Type: PLACEBO_COMPARATOR; Interventions: Drug: Lumacaftor Placebo, Drug: Ivacaftor Placebo | Arm Label: Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Arm Label: Cohort 4: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Lumacaftor Placebo, Drug: Ivacaftor Placebo | Arm Label: Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Intervention Type: DRUG; Name: Lumacaftor; Assigned to Arm(s): Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h, Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h, Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE), Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO), Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h, Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h, Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO), Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE), Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO), Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h | Intervention Type: DRUG; Name: Lumacaftor Placebo; Assigned to Arm(s): Cohort 1: Placebo, Cohort 2 and 3: Placebo (HO and HE), Cohort 4: Placebo | Intervention Type: DRUG; Name: Ivacaftor Placebo; Assigned to Arm(s): Cohort 1: Placebo, Cohort 2 and 3: Placebo (HO and HE), Cohort 4: Placebo
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: VX-661 Plus Ivacaftor Combination Placebo, Drug: Ivacaftor placebo | Arm Label: VX-661/IVA; Type: EXPERIMENTAL; Interventions: Drug: VX-661 Plus Ivacaftor Combination, Drug: Ivacaftor | Intervention Type: DRUG; Name: VX-661 Plus Ivacaftor Combination; Assigned to Arm(s): VX-661/IVA | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): VX-661/IVA | Intervention Type: DRUG; Name: VX-661 Plus Ivacaftor Combination Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Ivacaftor placebo; Assigned to Arm(s): Placebo

Answer: A