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

Hoffmann-La Roche26 sites in 1 country305 target enrollmentApril 25, 2013

ConditionsIdiopathic Pulmonary Fibrosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Hoffmann-La Roche
Enrollment: 305
Locations: 26
Primary Endpoint: Change in Observed Predicted Forced Vital Capacity
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 25, 2013

End Date

August 15, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Change in Observed Predicted Forced Vital Capacity

Time Frame: Up to 4 years

Secondary Outcomes

Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)(Up to 4 years)
Progression-Free Survival (PFS)(Up to 4 years)
Proportion of Patients Taking Full Dose of Esbriet (pirfenidone)(Up to 4 years)
Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone)(Up to 4 years)
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the A Tool Quality of Life Questionnaire (ATAQ-IPF)(Up to 4 years)
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Health-Related Quality of Life Questionnaire (HRQOL)(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)(Up to 4 years)
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the EuroQol-5 Dimension Questionnaire (EQ-5D)(Up to 4 years)