Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2019-08-01
2027-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Symdeko
Patients who have a mutation that responds to a CFTR corrector from in vitro study will be given Symdeko, depending on the in vitro response pattern
Symdeko
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.
Ivacaftor
Patients who have mutation response to a potentiator of CFTR function will be given Ivacaftor monotherapy.. Patients with a mutation equivalent to wild type will be given Ivacaftor.
Symdeko
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.
Orkambi
Patients who have a mutation that responds to a CFTR corrector from in vitro study will be given Orkambi, depending on the in vitro response pattern
Symdeko
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.
Interventions
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Symdeko
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
ALL
No
Sponsors
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George Solomon
OTHER
Responsible Party
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George Solomon
Principal Investigator
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IMPACT-Solomon
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-300001867
Identifier Type: -
Identifier Source: org_study_id
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