Canadian Observational Study Evaluating the Long-term IMP... | NCT05200429

NCT05200429

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pre-Therapy Participants		All CF people with CF who do not have any known contraindications to CFTR modulator therapy and will be initiated on CFTR modulator therapy by their treating physician as part of clinical care are eligible and will be asked to participate in this study.	Drug: Trikafta

Name	Type	Description	Arm Group Labels	Other Names
Trikafta	Drug	Highly Effective CFTR Modulator Therapy	Pre-Therapy Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To examine the long-term pulmonary and nutritional effects of CFTR modulators.		5 years
To assess the long-term impact of CFTR modulators on patient-reported outcome measures including quality of life, disease burden, and physical activity.		5 years
To establish a bio-repository to enable further investigations of the effectiveness of CFTR modulator therapies on biological markers and predictors of response.		5 years
To establish the benefits of CFTR modulators compared to propensity-score matched historic CF populations followed in the Canadian CF registry.		5 years

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Alam Lakhani	Contact	604-875-2345	7606	alam.lakhani@cw.bc.ca
Britney Ha	Contact	604-875-2345	7606	britney.ha@cw.bc.ca

Name	Affiliation	Role
Jonathan Rayment, MDCM	University of British Columbia	Principal Investigator
Bradley Quon, MD	University of British Columbia	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
British Columbia Children's Hospital	Recruiting	Vancouver	British Columbia	V6H 3N1	Canada

References Module

No data available