Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.

Completed

Conditions studied: Cystic Fibrosis

In brief

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 overall health of individuals will be tracked for a year to see how effective triple combination therapy is in these people with severe cystic fibrosis disease.

Key facts

Study ID

NCT04038710

Run by

National Jewish Health

People needed

8

Starts

2019-09-05

Expected to finish

2021-02-26

Last updated by the study team

2021-03-11

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• National Jewish Health — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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