Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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|ClinicalTrials.gov Identifier: NCT02699879|
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment|
|Idiopathic Pulmonary Fibrosis||Drug: Pirfenidone|
|Study Type :||Observational|
|Actual Enrollment :||1009 participants|
|Official Title:||Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting|
|Actual Study Start Date :||February 16, 2012|
|Actual Primary Completion Date :||September 15, 2016|
|Actual Study Completion Date :||September 15, 2016|
Participants will receive pirfenidone orally according to the physician discretion.
Pirfenidone will be administered according to the physician discretion as part of standard care.
Other Name: Esbriet
- Percentage of participants with clinically significant ADRs of special interest [ Time Frame: up to 2 years ]
- Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions [ Time Frame: up to 2 years ]
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): NCT02699879
|Study Director:||Clinical Trials||Hoffmann-La Roche|