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Completed

NCT Number: NCT02699879

Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

This single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with IPF. The enrolment of participants will be completed within approximately 24 months. Participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. Treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Graz; Department for Respiratory Diseases, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A clinical decision has been made, prior to study enrolment, to prescribe Esbriet
  • Participants who are newly prescribed Esbriet therapy
  • Initiation of Esbriet therapy is not more than 30 days prior to study enrolment

Exclusion criteria

  • Participants receiving an investigational agent defined as any drug that has not been approved for marketing for any indication in the country of the participating site
  • Participant has received Esbriet therapy 30 days or more prior to current treatment course (e.g., prior participation in clinical trials)
  • Participant has any contraindication for the use of Esbriet, according to the current local version of the Summary of Product Characteristics (SPC)

Treatment and study plan

pirfenidone

Drug

Pirfenidone will be administered according to the physician discretion as part of standard care.

Other names: Esbriet

Primary outcomes

  1. Percentage of participants with clinically significant ADRs of special interest

    Time frame: up to 2 years

  2. Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions

    Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2016
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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