Personalized Theratyping Trial

Phase 1

Recruiting

• Conditions: Cystic Fibrosis

• Registration Number: NCT03587961
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-7-3
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Inclusion Criteria:<br><br> - Diagnosis of CF<br><br> - Age =6 y.o.<br><br> - CFTR mutation that may respond to approved correctors/potentiators in the opinion of<br> the study investigators<br><br> - Informed Consent/Assent<br><br> - Stable CF pulmonary regimen<br><br>Exclusion Criteria:<br><br> - Exacerbation requiring antibiotic or steroids for >28 days before trial entry<br><br> - Ongoing participation in a CFTR modulator study<br><br> - Active smoking in the past 6 months<br><br> - History of solid organ transplant<br><br> - Any condition which precludes the use of CFTR modulators: e.g. advanced cirrhosis,<br> End-stage Renal Disease (ESRD)<br><br> - Any condition that precludes the patient from participation in the opinion of the<br> investigator<br><br> - Any meds that have significant drug-drug interactions or any other off label use of<br> CFTR modulators

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
spirometry