This trial is active, not recruiting.

Condition idiopathic pulmonary fibrosis
Treatment pirfenidone
Sponsor Hoffmann-La Roche
Start date February 2012
End date August 2016
Trial size 1009 participants
Trial identifier NCT02699879, PIPF-025, WB29908


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Participants will receive pirfenidone orally according to the physician discretion.
pirfenidone Esbriet
Pirfenidone will be administered according to the physician discretion as part of standard care.

Primary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - A clinical decision has been made, prior to study enrolment, to prescribe pirfenidone - Participants who are newly prescribed pirfenidone therapy - Initiation of pirfenidone 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)

Additional Information

Official title Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.