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Observational Study to Evaluate Disease Course and Outcomes in Patients Treated With Esbriet (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF) in Canada

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02552849
First received: September 16, 2015
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
This is a multi-center, non-interventional study to assess and describe course and outcomes in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet (pirfenidone) in Canada, by measuring and reporting observed predicted forced vital capacity (FVC) change from baseline on an ongoing basis.

Condition Intervention
Idiopathic Pulmonary Fibrosis
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in Observed Predicted Forced Vital Capacity [ Time Frame: Up to 4 years ]

Secondary Outcome Measures:
  • Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone) [ Time Frame: Up to 4 years ]
  • Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the A Tool Quality of Life Questionnaire (ATAQ-IPF) [ Time Frame: Up to 4 years ]
  • Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Health-Related Quality of Life Questionnaire (HRQOL) [ Time Frame: Up to 4 years ]
  • Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH) [ Time Frame: Up to 4 years ]
  • Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the EuroQol-5 Dimension Questionnaire (EQ-5D) [ Time Frame: Up to 4 years ]
  • Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Up to 4 years ]
  • Progression-Free Survival (PFS) [ Time Frame: Up to 4 years ]
  • Proportion of Patients Taking Full Dose of Esbriet (pirfenidone) [ Time Frame: Up to 4 years ]

Estimated Enrollment: 400
Actual Study Start Date: April 25, 2013
Estimated Study Completion Date: June 28, 2019
Estimated Primary Completion Date: June 28, 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Overall study
Specific treatment, dose, and treatment duration will be decided by the investigator independently of the participation of a patient in the study.
Other: No intervention

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Idiopathic Pulmonary Fibrosis (IPF)
Criteria

Inclusion Criteria:

  • > or = 18 years of age
  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
  • Prescribed and/or currently taking Esbriet (pirfenidone) for the treatment of IPF

Exclusion Criteria:

  • Hypersensitivity to Esbriet (pirfenidone)
  • Concomitant use of fluvoxamine
  • Severe hepatic impairment or end-stage liver disease
  • Severe renal impairment or end-stage renal disease requiring dialysis
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02552849

Contacts
Contact: Reference Study ID Number: ML29808 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 2T9
Edmonton Respiratory Consultants & Edmonton Sleep Lab Recruiting
Edmonton, Alberta, Canada, T5J 3S9
Grey Nuns Community Hospital Recruiting
Edmonton, Alberta, Canada, T6L 5X8
Synergy Respiratory Care Recruiting
Sherwood Park, Alberta, Canada, T8H ON2
Canada, British Columbia
Kelowna Respiratory and Allergy Cllinic Recruiting
Kelowna, British Columbia, Canada, V1W 1V3
Mainra Rajesh R, Respirology Terminated
North Vancouver, British Columbia, Canada, V7M 2H9
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 2S3
St. Paul'S Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Winnipeg Clinic Recruiting
Winnipeg, Manitoba, Canada, R3C ON2
Canada, New Brunswick
Clinique de pneumologie de Moncton Respiratory Clinic Terminated
Moncton, New Brunswick, Canada, E1C 5K4
Dr. Graham W. Bishop Clinic Terminated
Saint John, New Brunswick, Canada, E2M 5J7
Canada, Newfoundland and Labrador
St. Clare'S Mercy Hospital Recruiting
St John's, Newfoundland and Labrador, Canada, A1C 5B8
Professional Medical Corporation Terminated
St. John's, Newfoundland and Labrador, Canada, A1C 2H3
Canada, Ontario
Burlington Lung Clinic Recruiting
Burlington, Ontario, Canada, L7N 3V2
Firestone Institute for Respiratory Health Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Hotel Dieu Hospital Recruiting
Kingston, Ontario, Canada, K7L 5G2
Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute Recruiting
London, Ontario, Canada, N6C 2R5
Credit Valley Professional Building Terminated
Mississauga, Ontario, Canada, L5M 2V8
Oshawa Clinic Active, not recruiting
Oshawa, Ontario, Canada, L1H 1B9
Carling Respiratory Services Terminated
Ottawa, Ontario, Canada, K1Y 4G2
Dr. Marc Newton Respirology Recruiting
Owen Sound, Ontario, Canada, N4K 3M6
Rosedale Chest Clinic Recruiting
Toronto, Ontario, Canada, M4X 1W4
Dr. Syed Anees Medicine Profession Corporation Recruiting
Windsor, Ontario, Canada, N8X 5A6
Dr Anil Dhar Professional Medicine Corporation Recruiting
Windsor, Ontario, Canada, N8X-5A6
Canada, Quebec
Hopital Notre-Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Clinique de pneumologie et du sommeil de Lanaudiere Recruiting
Saint-Charles-Borromee, Quebec, Canada, J6E 2B4
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02552849     History of Changes
Other Study ID Numbers: ML29808
Study First Received: September 16, 2015
Last Updated: March 21, 2017

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on April 28, 2017