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ongoing trials trial from www.clinicaltrials.gov

A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - Phase 3 - Not yet recruiting

  • Year: 2018
  • Date: March 6, 2018
  • Author: Vertex Pharmaceuticals Incorporated
Source

https://ClinicalTrials.gov/show/NCT03447249

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment

Participants

Cystic Fibrosis - 12 Years and older   (Child, Adult, Senior)

Interventions

Drug: VX-659|Drug: TEZ|Drug: IVA|Drug: Matched Placebos

Outcome measures

Absolute change in ppFEV1|Number of pulmonary exacerbations (PEx)|Absolute change in body mass index (BMI)|Absolute change in Sweat Chloride (SwCl)|Absolute change in Cystic Fibrosis Questionnaire Revised (CFQ-R) respiratory domain score|Time-to-first PEx|Absolute change in BMI z score|Absolute change in body weight|Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs)|Observed pre-dose concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA

Keywords: Adult; Aged; CFTR Modulators; Genetic Predisposition to Disease; pharmacological_intervention; placebo; VX-770; VX-661; ivacaftor; Aminophenols; tezacaftor; VX-659;