Personalized Theratyping Trial for Cystic Fibrosis

This study is for people with Cystic Fibrosis (CF) who have certain genetic changes (mutations) that are not currently approved for treatment with specific CF medications. Researchers want to see if existing CF drugs like Symdeko (Tezacaftor/Ivacaftor), Orkambi (Ivacaftor and Lumacaftor), or Kalydeco (Ivacaftor) could help improve lung function in patients with these specific mutations. You might be able to join if you are at least 6 years old, have a CF diagnosis, and your CF doctor thinks your mutation might respond to these types of drugs. The main goal is to measure your lung function (spirometry) after 32 weeks to see if the treatment is effective. This study is currently recruiting a small group of 20 participants.

Study design: This is an interventional study with a planned enrollment of 20 participants. It is exploring the use of existing CFTR modulators for new patient groups.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Your lung function will be measured at 32 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Personalized Theratyping Trial

Recruiting

EARLY_PHASE1Ages 6+InterventionalTreatment

George Solomon

~20 participants

Updated 2026-02-02 on ClinicalTrials.gov

What's tested:Symdeko

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

spirometry

Measured over 32 weeks

Conditions

Cystic Fibrosis

Where it's being run

1 sites across 1 states

Alabama1

Who to contact

Heather Hathorne, PhD

[email protected]

205-638-9568

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

spirometry32 weeks
change in lung function as measured via spirometry

Trialytics