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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 day 1 up to week 100
Awards & highlights

Study Summary

This trial will study how safe and effective the drug elexacaftor is for people with cystic fibrosis who are 6 years old or older and have the F/MF genotypes.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to week 100
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to week 100 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 Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Absolute Change in Lung Clearance Index 2.5 (LCI 2.5)
Absolute Change in Sweat Chloride (SwCl)

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: ELX/TEZ/IVAExperimental Treatment2 Interventions
Participants will receive ELX/TEZ/IVA in the morning and IVA 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
32,267 Total Patients Enrolled
126 Trials studying Cystic Fibrosis
17,629 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.

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

"There is pre-existing evidence of ELX/TEZ/IVA's efficacy and safety, as this is a Phase 3 trial."

Answered by AI

Are ELX/TEZ/IVA clinical trials ongoing or have they been completed?

"At this moment, there are 22 different ongoing clinical trials investigating ELX/TEZ/IVA. Out of these, 15 are in Phase 3. Additionally, there are 1038 different locations where these trials are taking place, with some notable sites in Bochum and California."

Answered by AI

Can you please explain the standard application for ELX/TEZ/IVA?

"People with cystic fibrosis who have two copies of the F508del mutation in the CFTR gene can be given ELX/TEZ/IVA."

Answered by AI

Is this research innovative or cutting-edge in any way?

"Vertex Pharmaceuticals Incorporated sponsored the first trial for ELX/TEZ/IVA in 2015. 1044 patients completed the Phase 3 drug approval stage of the trial. Since then, there have been 22 active studies across 110 cities and 23 countries. 85 trials in total have been completed."

Answered by AI

Are there any inclusions or exclusions for this research project?

"Unfortunately, this cystic fibrosis clinical trial is not recruiting patients right now. If you're interested in other studies, there are 429 clinical trials actively enrolling participants with cystic fibrosis and 22 studies for ELX/TEZ/IVA that are actively looking for participants."

Answered by AI

How many total subjects are included in this research?

"Though this trial was first posted on January 11th, 2021, it is not currently looking for participants. The most recent update was on February 4th, 2022. There are 429 other trials actively searching for patients with cystic fibrosis and 22 studies for ELX/TEZ/IVA that are also looking for patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF Genotypes
2021. "A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF Genotypes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04545515.
~28 spots leftby Apr 2025
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