NCT05844449

Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Year of Age and Older

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis (CF).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VNZ/TEZ/D-IVA	Fixed-dose combination tablets or granules for oral administration.

Timeline

• Start date: 2023-08-11
• Primary completion: 2029-07-30
• Completion: 2029-07-30
• First posted: 2023-05-06
• Last updated: 2026-02-05

Locations

37 sites across 10 countries: United States, Australia, Canada, France, Germany, Netherlands, New Zealand, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study