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Personalized Theratyping Trial

RecruitingEarly phase 1

Who can join

Ages 6 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Diagnosis of CF
* Age ≥6 y.o.
* CFTR mutation that may respond to approved correctors/potentiators in the opinion of the study investigators
* Informed Consent/Assent
* Stable CF pulmonary regimen

Exclusion Criteria:

* Exacerbation requiring antibiotic or steroids for \>28 days before trial entry
* Ongoing participation in a CFTR modulator study
* Active smoking in the past 6 months
* History of solid organ transplant
* Any condition which precludes the use of CFTR modulators: e.g. advanced cirrhosis, End-stage Renal Disease (ESRD)
* Any condition that precludes the patient from participation in the opinion of the investigator
* Any meds that have significant drug-drug interactions or any other off label use of CFTR modulators

About the study

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.

What is being tested

Sponsor: George Solomon · Participants: 20 · Started: Aug 1, 2019

Contact the study team

Official record on ClinicalTrials.gov — NCT03587961

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.