A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Subjects With Cystic Fibrosis (CF)

  • STATUS
    Recruiting
  • End date
    Sep 26, 2022
  • participants needed
    100
  • sponsor
    Vertex Pharmaceuticals Incorporated
Updated on 19 January 2022
fibrosis
forced expiratory volume
ivacaftor
tezacaftor
elexacaftor

Summary

This study will evaluate the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on cough and physical activity using wearable technology in CF participants.

Details
Condition Cystic Fibrosis
Treatment IVA, ELX/TEZ/IVA
Clinical Study IdentifierNCT04969224
SponsorVertex Pharmaceuticals Incorporated
Last Modified on19 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Forced expiratory volume in 1 second (FEV1) value ≥30% and ≤90% predicted
Heterozygous for CF transmembrane conductance regulator gene (CFTR) F508del mutation and a minimal function mutation (F/MF genotypes)

Exclusion Criteria

Clinically significant liver cirrhosis
Solid organ or hematological transplantation
Non-ambulatory status
Lung infection with organisms associated with a more rapid decline in pulmonary status
Other protocol defined Inclusion/Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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