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ongoing trials trial from www.clinicaltrials.gov

A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF) - Phase 3 - Not yet recruiting

  • Year: 2021
  • Date: September 2021
  • Author: Vertex Pharmaceuticals Incorporated
Source

https://ClinicalTrials.gov/show/NCT05033080

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

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

Participants

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

Interventions

Drug: VX-121/TEZ/D-IVA|Drug: ELX/TEZ/IVA|Drug: IVA|Drug: Placebo (matched to VX-121/TEZ/D-IVA)|Drug: Placebo (matched to ELX/TEZ/IVA)|Drug: Placebo (matched to IVA)

Outcome measures

Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24|Absolute Change From Baseline in Sweat Chloride (SwCl) Through Week 24|Proportion of Participants With SwCl <60 Millimole per Liter (mmol/L) Through Week 24 (Pooled With Data From Study VX20-121-103)|Proportion of Participants With SwCl <30 mmol/L Through Week 24 (Pooled With Data From Study VX20-121-103)

Keywords: Adult; Aged; CFTR Modulators; Genetic Predisposition to Disease; pharmacological_intervention; placebo; VX-121; Aminophenols; tezacaftor; VX-770; VX-661; ivacaftor; VX-445; vanzacaftor; elexacaftor; Trikafta;