Status:
COMPLETED
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
Lead Sponsor:
National Jewish Health
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Brief Summary
This is an observational study of people with severe cystic fibrosis that are eligible for Vertex's triple combination therapy through its expanded access. Pulmonary health, intestinal health, and the...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Cystic Fibrosis
- Ability to reproducibly perform spirometry (according to ATS criteria)
- Physician decision to treat with TCT through the EAP program
- Ability to understand and sign a written informed consent or assent and comply with the requirements of the study
Exclusion
- History of hypersensitivity to VX 445, VX 659, tezacaftor and/or ivacaftor
- Any acute lower respiratory symptoms treated with oral, inhaled or IV antibiotics or systemic corticosteroids within the 2 weeks prior to Visit 1.
- Major or traumatic surgery within 12 weeks prior to Visit 1.
- Initiation of any new chronic therapy (e.g., ibuprofen, Pulmozyme®, hypertonic saline, azithromycin, TOBI®, Cayston®) within 4 weeks prior to Visit 1.
- Use of an investigational agent within 28 days prior to Visit 1.
- History of lung or liver transplantation or listing for organ transplantation.
Key Trial Info
Start Date :
September 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04038710
Start Date
September 5 2019
End Date
February 26 2021
Last Update
March 11 2021
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206