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The purpose of this study is to support the clinical validation of a new assay to measure the levels of ivacaftor, tezacaftor, and elexacaftor (the components of Trikafta) in the bloodstream in order to achieve greater understanding of the effectiveness of this medication in all people with cystic fibrosis. Blood will be drawn at 3.0, 4.5, and 6.0 hours after taking the medication in the morning.
Blood samples will be collected to measure steady state blood levels for participants who are being treated with elexacaftor/tezacaftor/ivacaftor (ETI). This study is being conducted to evaluate drug dosing in people with cystic fibrosis. The aim of this study is to support clinical validation of pharmacokinetics launch of the elexacaftor/tezacaftor/ivacaftor blood serum level assay to demonstrate instrument capabilities to pass ADx validation criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with Cystic Fibrosis who are taking ETI that has reached a steady state dosing level. | Blood samples will be collected from people with CF who are taking ETI at a continuous dosing regimen for a minimum of 14 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with ETI in expected reference range | Patient expected reference range determined by initial U.S FDA (2019 approval documentation): Cmax for Elexacaftor, Tezacaftor, Ivacaftor are 8.7± 2.1, 6.8 ± 1.5, 1.2 ± 0.3 mcg/mL, respectively. Limit of quantification estimated to be within +/- 20% of lowest calibration point of 0.2 mcg/mL. | 3 hours, 4.5 hours and 6 hours after taking the medication |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 100 people with CF who attend the Adult CF Program of Colorado at National Jewish Health and are actively taking ETI hat has reached steady state dosing levels of ETI (defined as a continuous dosing regimen for a minimum of 14 days) will be recruited and enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Jerry Nick, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| St. Joseph Hospital |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Denver |
| Colorado |
| 80206 |
| United States |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |