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Clinical trial

A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

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Last updated:28th Aug 2019
Identifier: NCT04058353

This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
Actual Study Start Date: August 28, 2019
Estimated Primary Completion Date: October 2020
Estimated Study Completion Date: October 2020

Arms:
- Experimental:
Triple Combination Arm
- Active Comparator: Control Arm

Category Value
Date last updated at source 2019-10-07
Study type(s) Interventional
Expected enrolment 250
Study start date 2019-08-28
Estimated primary completion date 2020-10-01

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