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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
Currently participating in study VX17-659-105 (NCT03447262)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through week 100
Awards & highlights

Study Summary

This trial will study the long-term safety of a drug combination for treating cystic fibrosis.

Eligible Conditions
  • Cystic Fibrosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through week 100
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through 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
Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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
Part A: Participants received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks. Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IVA
2018
Completed Phase 3
~5230
ELX/TEZ/IVA
2019
Completed Phase 3
~3370

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
31,929 Total Patients Enrolled
126 Trials studying Cystic Fibrosis
17,291 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.

What patients does ELX/TEZ/IVA usually help?

"ELX/TEZ/IVA is a medication frequently used to treat patients with the homozygous for f508del mutation in the cftr gene. Other conditions that this drug can be used to target include cystic fibrosis (cf), cystic fibrosis, homozygous for the f508del cftr mutation, and ivacaftor-responsive cftr mutation."

Answered by AI

Has the food and drug administration greenlit ELX/TEZ/IVA?

"There is some evidence of efficacy and extensive data supporting safety, so this medication received a score of 3."

Answered by AI

In how many different geographical areas is this study being conducted?

"The primary locations for this clinical trial are Cincinnati Children's Hospital Medical Center, Johns Hopkins Hospital and Duke University Medical Center. In addition, there are 49 other sites where this study is taking place."

Answered by AI

Are ELX/TEZ/IVA drugs being trialed elsewhere for safety and efficacy?

"As of now, there are 22 clinical studies ongoing that involve ELX/TEZ/IVA with 15 being in Phase 3. Many research centres for this drug are based in Bochum and California; though, globally, there are 1038 medical facilities conducting trials for ELX/TEZ/IVA."

Answered by AI

How many individuals are participating in this research project?

"Unfortunately, this particular trial is not presently looking for patients. The listing was first put on August 9th 2019 but was last updated 6282022. However, there are 432 other trials for cystic fibrosis and 22 different ones for ELX/TEZ/IVA that are currently admitting patients."

Answered by AI

Are volunteers still needed for this research project?

"The clinical trial described is not currently enrolling patients, as per the most recent update on clinicaltrials.gov. This information was last updated on June 28th, 2022 and the trial was originally posted on August 9th, 2019. There are 454 other trials that are actively recruiting participants at this time."

Answered by AI

Is this a new or unique clinical trial?

"Vertex Pharmaceuticals Incorporated sponsored the first clinical trial for ELX/TEZ/IVA in 2015. The Phase 3 drug approval stage was completed with 1044 participants. Since then, 85 additional studies have been carried out in 23 countries across 110 cities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
2019. "A Study Evaluating the Long-term Safety of VX-445 Combination Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04043806.
~81 spots leftby Apr 2025
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