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

NCT ID: NCT02552849

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

305 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-25

Study Completion Date

2017-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Overall study

Specific treatment, dose, and treatment duration will be decided by the investigator independently of the participation of a patient in the study.

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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South Health Campus/Alberta Health Services/ University of Calgary

Calgary, Alberta, Canada

Site Status

Edmonton Respiratory Consultants & Edmonton Sleep Lab

Edmonton, Alberta, Canada

Site Status

Grey Nuns Community Hospital

Edmonton, Alberta, Canada

Site Status

Synergy Respiratory Care

Sherwood Park, Alberta, Canada

Site Status

Kelowna Respiratory and Allergy Cllinic

Kelowna, British Columbia, Canada

Site Status

Mainra Rajesh R, Respirology

North Vancouver, British Columbia, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

St. Paul's Hospital University of British Colambia Division of Hematology

Vancouver, British Columbia, Canada

Site Status

Winnipeg Clinic

Winnipeg, Manitoba, Canada

Site Status

Clinique de pneumologie de Moncton Respiratory Clinic

Moncton, New Brunswick, Canada

Site Status

Dr. Graham W. Bishop Clinic

Saint John, New Brunswick, Canada

Site Status

Professional Medical Corporation

St. John's, Newfoundland and Labrador, Canada

Site Status

St. Clare'S Mercy Hospital

St. John's, Newfoundland and Labrador, Canada

Site Status

Burlington Lung Clinic

Burlington, Ontario, Canada

Site Status

Firestone Institute for Respiratory Health

Hamilton, Ontario, Canada

Site Status

Hotel Dieu Hospital

Kingston, Ontario, Canada

Site Status

Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute

London, Ontario, Canada

Site Status

Credit Valley Professional Building

Mississauga, Ontario, Canada

Site Status

Oshawa Clinic

Oshawa, Ontario, Canada

Site Status

Carling Respiratory Services

Ottawa, Ontario, Canada

Site Status

Dr. Marc Newton Respirology

Owen Sound, Ontario, Canada

Site Status

Toronto General Hospital; Investigational Pharmacy Services ENB - 217 (Pharmacy Receiving)

Toronto, Ontario, Canada

Site Status

Dr. Syed Anees Medicine Profession Corporation

Windsor, Ontario, Canada

Site Status

Dr Anil Dhar Professional Medicine Corporation

Windsor, Ontario, Canada

Site Status

Hopital Notre-Dame

Montreal, Quebec, Canada

Site Status

Clinique de pneumologie et du sommeil de Lanaudiere

Saint-Charles-Borromée, Quebec, Canada

Site Status

Countries

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United Kingdom Canada

Other Identifiers

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ML29808

Identifier Type: -

Identifier Source: org_study_id