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ongoing trials trial from other registries

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis

  • Year: 2021
  • Date:
  • Author:
Source

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000713-17/NO/

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

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

Participants

Principal inclusion criteria: 1.Subject (or his or her legally appointed and authorized representative) will sign and date an informed consent form (ICF), and, when appropriate, an assent form.

Interventions

VX121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in subjects with cystic fibrosis (CF)

Outcome measures

Primary end point(s): Safety and tolerability of long-term treatment with VX-121/TEZ/D-IVA based on adverse events (AEs), clinical laboratory values, ECGs, vital signs, and pulse oximetry

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