Status:
COMPLETED
: TRANSITION: An Observational Study of Transition From Lumacaftor/Ivacaftor to Tezacaftor/Ivacaftor (Tez/Iva)
Lead Sponsor:
National Jewish Health
Conditions:
Cystic Fibrosis (CF)
Eligibility:
All Genders
12+ years
Brief Summary
This study is a single center study of clinical and laboratory outcomes in patients ≥ 12 who transition from use of Orkambi to tez/iva. Clinical and laboratory measurements will be measured at baselin...
Detailed Description
While cystic fibrosis (CF) therapeutic development previously targeted the signs and symptoms of the disease, in the last 5 years, two drugs that treat the basic defect in CF have been approved, ivaca...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of CF
- Male or female subjects greater than or equal to 12 years of age
- Ability to reproducibly perform spirometry testing
- Physician decision to treat with tezacaftor/ivacaftor (Smydeko)
- Ability to understand and sign a written informed consent or assent and comply with the requirements of the study
- Continuous use of orkambi for at least 1 month prior to visit 1
Exclusion
- History of hypersensitivity to tezacaftor and/or ivacaftor
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Any acute lower respiratory symptoms treated with oral, inhaled or intravenous antibiotics (IV) or systemic corticosteroids within the 2 weeks prior to Visit 1
- Major or traumatic surgery within 12 weeks prior to Visit 1
- For women of child-bearing potential: a positive pregnancy test at Visit 1
- Unable or unwilling to fast (including no enteric tube feedings) for at least 6 hours prior each visit
- Initiation of any new chronic therapy within 4 weeks prior to Visit 1
- Use of an investigational agent within 28 days prior to Visit 1
- Use of chronic oral corticosteroids within 28 days prior to Visit 1
- Treatment for nontuberculous mycobacterial (NTM) infection, consisting of greater than or equal to two antibiotics (oral, IV, and/or inhaled) within 28 days prior to Visit 1
- History of lung or liver transplantation, or listing for organ transplantation
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03445793
Start Date
March 1 2018
End Date
November 1 2019
Last Update
January 23 2024
Active Locations (1)
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1
National Jewish Heatlh
Denver, Colorado, United States, 80206