NCT05111145

A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF)

A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in participants with CF who are 12 years of age or older.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	ELX/TEZ/IVA	Fixed-dose combination tablets for oral administration.
DRUG	IVA	Tablets for oral administration.

Timeline

• Start date: 2022-01-14
• Primary completion: 2022-12-20
• Completion: 2022-12-20
• First posted: 2021-11-08
• Last updated: 2023-07-11
• Results posted: 2023-07-11

Locations

24 sites across 5 countries: Australia, Belgium, Canada, Czechia, Spain

Regulatory

• FDA-regulated drug study