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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 investigates the safety, effectiveness and effects of a drug to treat cystic fibrosis in people with a certain gene mutation.
Who is the study for?
This trial is for people with cystic fibrosis who have at least one non-F508del mutation responsive to the drug combo ELX/TEZ/IVA. Participants should have completed treatment in a previous study or, if interrupted, made it to the last scheduled visit of that study's treatment period.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of a drug combination called Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) for treating cystic fibrosis in patients without the F508del mutation.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with CFTR modulators like ELX/TEZ/IVA may include chest discomfort, dizziness, rash, abdominal pain, increased liver enzymes, respiratory events and headaches.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 up to week 100
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to week 100
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 Body Mass Index (BMI)
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain (RD) Score
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)
+3 moreTrial 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
Ivacaftor
FDA approved
Tezacaftor
FDA approved
Find a Location
Who is running the clinical trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
32,091 Total Patients Enrolled
126 Trials studying Cystic Fibrosis
17,453 Patients Enrolled for Cystic Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had trouble tolerating the study drug in a previous study.
Research Study Groups:
This trial has the following groups:- Group 1: ELX/TEZ/IVA
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the US Food and Drug Administration given authorization to ELX/TEZ/IVA?
"The trio of ELX/TEZ/IVA has been assessed to be a safe medication, with reliable data attesting to its efficacy and safety. Power's team consequently rated it with the maximum score of 3."
Answered by AI
How many venues are hosting this research endeavor?
"The research trial is operating in 40 different sites, such as HagaZiekenhuis van den Haag in Den Haag, Kinderspital Zuerich in Zürich, and Cliniques Universitaires de Bruxelles Hopital Erasme in Brussels."
Answered by AI
Does this experiment currently have room for additional volunteers?
"The data hosted on clinicaltrials.gov confirms that this particular medical trial is not presently accepting volunteers, but was originally posted on November 23rd 2022 and last edited March 22nd 2023. Despite the inaccessibility of this study, 424 other clinical trials are currently looking for participants at present."
Answered by AI
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