Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT05200429

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Trikafta

Study Details

Brief summary:

This observational study intends to investigate health trends and data in cystic fibrosis patients all across Canada that are receiving modulator treatment so researchers can determine if CFTR treatments are effective over a long period of time and if so, which treatments work best for each individual. The study will collect clinical data from routine standard of care, patient reported outcomes via survey data and samples for a biobank.

Conditions

Cystic Fibrosis

Study ID

NCT05200429

Start date

Nov 1, 2021

Status verified date

Jan, 2022

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Prescribed a CFTR modulator therapy and planning to commence modulator therapy within 30 days OR planning to switch modulator therapies within 30 days
  • Participates in the Canadian Cystic Fibrosis Registry (CCFR)
  • Informed consent by participant, or parent/legal guardian or assent

Exclusion Criteria:

  • Known contraindications to CFTR modulator therapy

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Trikafta

Highly Effective CFTR Modulator Therapy

Primary outcome measure

  • To examine the long-term pulmonary and nutritional effects of CFTR modulators. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 5 years ]
  • To establish the benefits of CFTR modulators compared to propensity-score matched historic CF populations followed in the Canadian CF registry. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Alam Lakhani

604-875-2345alam.lakhani@cw.bc.ca

Britney Ha

604-875-2345britney.ha@cw.bc.ca

Locations

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Britney Ha

604-875-2345Britney.Ha@cw.bc.ca

Vanessa Diamond

604-875-2345vanessa.diamond@bcchr.ca

Principal Investigator:

Jonathan Rayment, MDCM

St Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Ronak Salamat

604-806-9158rsalamatravandi@providencehealth.bc.ca

Taryn Leach

tleach@providencehealth.bc.ca

Principal Investigator:

Bradley Quon, MD

More Information

Sponsor

University of British Columbia

Last update posted

Jan 20, 2022

Last verified

Jan, 2022

Keywords

  • Trikafta
  • Cystic Fibrosis
  • CFTR Modulator Therapy
  • Respiratory Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-01-20.