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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 up to 5 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
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.
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.
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ELX/TEZ/IVAExperimental Treatment2 Interventions
Part A: Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening for 96 weeks.
Part B: Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening for an additional 96 weeks.
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
255 Previous Clinical Trials
34,388 Total Patients Enrolled
128 Trials studying Cystic Fibrosis
17,648 Patients Enrolled for Cystic Fibrosis
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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.
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