Personalized Theratyping Trial

Description

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.

Conditions

Cystic Fibrosis

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Study Overview

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Study Details

Study overview

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.

Personalized Theratyping Trial

Personalized Theratyping Trial

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

6 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Study Record Dates

2026-09-01