Personalized Theratyping Trial

ConditionCystic Fibrosis

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age6+

SponsorGeorge Solomon

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Symdeko
Drug
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.

Treatment groups

20 Participants

are divided into 3 treatment groups

Group A: SymdekoExperimental treatment 1 intervention

Group B: IvacaftorExperimental treatment 1 intervention

Group C: OrkambiExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

spirometry

change in lung function as measured via spirometry

Time frame

32 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

George Solomon

Lead sponsor

University of Alabama at Birmingham

Sponsor institution

Source ClinicalTrials.gov

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