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CFTR Modulator

ELX/TEZ/IVA for Cystic Fibrosis

Phase 3
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8 through week 12
Awards & highlights

Study Summary

This study will evaluate the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on cough and physical activity using wearable technology in CF participants.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8 through week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 through week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Reduction From Baseline in Cough Frequency (Cough Events Per Day) to the Average of Week 8 Through Week 12
Secondary outcome measures
Absolute Change From Baseline in Total Step Count Per Day to the Average of Week 8 Through Week 12

Trial Design

1Treatment groups
Experimental Treatment
Group I: ELX/TEZ/IVAExperimental Treatment2 Interventions
Participants received ELX 200 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the treatment period approximately 13 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ELX/TEZ/IVA
2019
Completed Phase 3
~3370
IVA
2018
Completed Phase 3
~5230

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
32,305 Total Patients Enrolled
126 Trials studying Cystic Fibrosis
17,667 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF)
2021. "A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04969224.
~23 spots leftby Apr 2025
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