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Canadian Observational Study Evaluating the Long-term IMPACT of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators on People With CF (Can-IMPACT CF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05200429
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : January 20, 2022
Sponsor:
Information provided by (Responsible Party):
Jonathan Rayment, University of British Columbia

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.

Condition or disease Intervention/treatment
Cystic Fibrosis Drug: Trikafta

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Canadian Observational Study Evaluating the Long-term IMPACT of CFTR (Can-IMPACT CF)
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
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
Highly Effective CFTR Modulator Therapy
Other Name: Elexacaftor/Tezacaftor/Ivacaftor




Primary Outcome Measures :
  1. To examine the long-term pulmonary and nutritional effects of CFTR modulators. [ Time Frame: 5 years ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Biospecimen Retention:   Samples Without DNA
Urine, Stool and Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05200429


Contacts
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Contact: Alam Lakhani 604-875-2345 ext 7606 alam.lakhani@cw.bc.ca
Contact: Britney Ha 604-875-2345 ext 7606 britney.ha@cw.bc.ca

Locations
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Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Britney Ha    604-875-2345 ext 7606    Britney.Ha@cw.bc.ca   
Contact: Vanessa Diamond    604-875-2345 ext 7606    vanessa.diamond@bcchr.ca   
Principal Investigator: Jonathan Rayment, MDCM         
St Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Ronak Salamat    604-806-9158    rsalamatravandi@providencehealth.bc.ca   
Contact: Taryn Leach       tleach@providencehealth.bc.ca   
Principal Investigator: Bradley Quon, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Jonathan Rayment, MDCM University of British Columbia
Principal Investigator: Bradley Quon, MD University of British Columbia
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Responsible Party: Jonathan Rayment, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT05200429    
Other Study ID Numbers: H21-01707
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Rayment, University of British Columbia:
Trikafta
Cystic Fibrosis
CFTR Modulator Therapy
Respiratory Disease
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Ivacaftor
Elexacaftor
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action