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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 from baseline up to week 196
Awards & highlights

Study Summary

This trial will study the effects of a new drug combination on people with cystic fibrosis.

Who is the study for?
This clinical trial is for people aged 6 and older with cystic fibrosis who have completed treatment in a previous study (VX18-445-106 Part B) or had interruptions but finished the visits. It's not open to those who couldn't tolerate the study drug before.Check my eligibility
What is being tested?
The trial tests long-term safety and effectiveness of a triple combination therapy using elexacaftor, tezacaftor, and ivacaftor for cystic fibrosis. The goal is to see how well patients do over an extended period on this medication regimen.See study design
What are the potential side effects?
While specific side effects are not listed here, common issues with medications like ELX/TEZ/IVA may include digestive problems, chest discomfort, rash, dizziness or liver-related issues. Long-term studies like this one help identify any additional risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to week 196
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to week 196 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability as assessed by adverse events (AEs) and serious adverse events (SAEs)
Secondary outcome measures
Absolute change in BMI-for-age z-score
Absolute change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score
Absolute change in body mass index (BMI)
+9 more

Side effects data

From 2022 Phase 3 trial • 458 Patients • NCT04043806
25%
Cough
23%
Infective pulmonary exacerbation of cystic fibrosis
20%
Headache
16%
Upper respiratory tract infection
15%
Sputum increased
14%
Pyrexia
13%
Oropharyngeal pain
13%
Nasopharyngitis
11%
Nasal congestion
10%
Fatigue
10%
Viral upper respiratory tract infection
9%
Nausea
9%
Immunisation reaction
9%
Alanine aminotransferase increased
9%
Blood creatine phosphokinase increased
9%
Haemoptysis
8%
Rhinorrhoea
7%
Abdominal pain
7%
Diarrhoea
7%
COVID-19
7%
Sinusitis
7%
Aspartate aminotransferase increased
7%
Back pain
6%
Arthralgia
6%
Dyspnoea
6%
Productive cough
6%
Sinus congestion
6%
Rash
5%
Vomiting
5%
Pain
5%
Myalgia
5%
Respiration abnormal
2%
Pneumonia
1%
Distal intestinal obstruction syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: ELX/TEZ/IVA
Part B: ELX/TEZ/IVA

Trial Design

1Treatment groups
Experimental Treatment
Group I: Triple Combination ArmExperimental Treatment2 Interventions
Subjects will receive ELX/TEZ/IVA TC in the morning and IVA as mono tablet in the evening.
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
32,323 Total Patients Enrolled
126 Trials studying Cystic Fibrosis
17,685 Patients Enrolled for Cystic Fibrosis

Media Library

ELX/TEZ/IVA (CFTR Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04183790 — Phase 3
Cystic Fibrosis Research Study Groups: Triple Combination Arm
Cystic Fibrosis Clinical Trial 2023: ELX/TEZ/IVA Highlights & Side Effects. Trial Name: NCT04183790 — Phase 3
ELX/TEZ/IVA (CFTR Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04183790 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the required conditions able to participate in this experiment right now?

"This study is not recruiting patients at the moment, as per clinicaltrials.gov. The trial was first posted on February 17th 2020 and updated most recently on February 4th 2022. There are 454 other trials that are currently looking for participants."

Answered by AI

For what reasons is ELX/TEZ/IVA typically given to patients?

"ELX/TEZ/IVA is an effective treatment for cystic fibrosis, and patients who are homozygous for the f508del cftr mutation in the cftr gene can especially benefit from this medication."

Answered by AI

Has the FDA cleared ELX/TEZ/IVA for use?

"ELX/TEZ/IVA is considered safe by our team at Power, who gave it a score of 3. This is based on the fact that this drug has entered Phase 3 trials, meaning there is evidence of both efficacy and safety."

Answered by AI

How many different branches is this study overseen by?

"There are 15 active clinical trial sites for this medication, which are situated in Vancouver, Columbus, Minneapolis and a dozen other cities. To reduce the burden of travel, it is recommended that you select a site close to your location."

Answered by AI

Has this clinical trial been conducted before?

"There are 22 ongoing clinical trials for ELX/TEZ/IVA in 23 countries and 110 cities. The first trial was sponsored by Vertex Pharmaceuticals Incorporated and completed Phase 3 drug approval in 2015. 1044 participants were enrolled. Since then, 85 more studies have been completed."

Answered by AI

Are there other research studies that have looked at ELX/TEZ/IVA?

"At the moment, 22 clinical trials are investigating ELX/TEZ/IVA. Of these ongoing studies, 15 have reached Phase 3. Most of the research being conducted for ELX/TEZ/IVA is happening in Bochum and California; however, there are 1038 total locations running experiments related to this treatment."

Answered by AI

How many people have volunteered to take part in this experiment?

"This clinical trial is not actively searching for participants at this time. The study was initially posted on 2/17/2020 and was most recently updated on 2/4/2022. If you are searching for other studies, there are currently 432 clinical trials actively recruiting patients with cystic fibrosis and 22 studies for ELX/TEZ/IVA that have open enrolment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older
2020. "Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04183790.
~12 spots leftby Apr 2025
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