ELX/TEZ/IVA for Cystic Fibrosis

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Vertex Pharmaceuticals Incorporated

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of three medications to help people with cystic fibrosis. The medications work together to fix a broken protein in the body, which can improve lung function and overall health.

Research Team

Eligibility Criteria

This trial is for people aged 2 and older with cystic fibrosis who have previously participated in a related study (VX20-445-111 Part B) without permanently stopping the study drug. Those with a history of not following treatment or procedures well, or intolerance to the study drug in the previous research, cannot join.

Inclusion Criteria

Completed study drug treatment in the parent study (VX20-445-111 Part B, NCT04537793), or had study drug interruption(s) in the parent study, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of the parent study

Exclusion Criteria

I have had issues following treatment or study rules in the past.

You had a bad reaction to the study drug in a previous study.

Treatment Details

Interventions

ELX/TEZ/IVA (CFTR Modulator)
IVA (CFTR Modulator)

Trial OverviewThe trial is looking at long-term safety and effectiveness of a combination medication (elexacaftor/tezacaftor/ivacaftor) for cystic fibrosis. It will assess how well patients tolerate this treatment over time and its impact on their condition.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ELX/TEZ/IVAExperimental Treatment2 Interventions

Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.

ELX/TEZ/IVA is already approved in Canada for the following indications:

Approved in Canada as Trikafta for:

Cystic fibrosis in patients aged 2 years and older with at least one copy of the F508del mutation in the CFTR gene or another mutation responsive to treatment