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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 March 2021 |
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Main ID: |
NCT04038710 |
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Date of registration:
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26/07/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
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Scientific title:
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An Observational Study of the Effects on Clinical Outcomes of Expanded Access Program of Vertex Triple Combination Therapy. |
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Date of first enrolment:
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September 5, 2019 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04038710 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Derek Low, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Jewish Health |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Triple combination therapy
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Primary Outcome(s)
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pulmonary function
[Time Frame: For a year post initiation of therapy.]
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Secondary Outcome(s)
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CFQ-R score
[Time Frame: For a year following the initiation of triple combination therapy.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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