RecruitingEarly Phase 1NCT03587961

Personalized Theratyping Trial


Sponsor

George Solomon

Enrollment

20 participants

Start Date

Aug 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs.


Eligibility

Min Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This study (called the Personalized Theratyping Trial) tests whether CF (cystic fibrosis) corrector and potentiator drugs approved for certain mutations might also help patients with other, less common CF mutations, using lab tests on patient samples to guide personalized treatment decisions. **You may be eligible if...** - You have been diagnosed with cystic fibrosis (CF) - You are 6 years of age or older - You have a CF gene mutation (CFTR mutation) that study investigators think might respond to approved corrector or potentiator drugs - Your CF lung treatment regimen has been stable - You are able to provide informed consent or assent **You may NOT be eligible if...** - You recently had a CF flare-up requiring antibiotics or steroids for more than 28 days before joining the study - You are currently enrolled in another study involving CFTR modulator drugs - You have smoked within the past 6 months - You have had a solid organ transplant - You have advanced liver disease (cirrhosis) or end-stage kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSymdeko

explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT03587961


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