CFDB - Cystic Fibrosis DataBase

  1. Home
  2. Database
Search (?)
at least one term
all terms
Advanced search
ongoing trials trial from other registries

A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation

  • Year: 2021
  • Date:
  • Author:
Source

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005320-38/ES/

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

Controlled: Yes.1 Randomised: Yes.2 Open: No.3 Single blind: No.4 Double blind: Yes.5 Parallel group: No.6 Cross over: No

Participants

Subjects (male or female) 6 years of age and older with stable CF disease, FEV1 value >40% and <90% of predicted

Interventions

The efficacy and pharmacodynamics (PD) of ELX/TEZ/IVA

Outcome measures

Primary end point(s): Absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1) through Week 24

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