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

Roche

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Pirfenidone

Study type: Observational

Funder types: Industry

Identifiers

NCT02699879

PIPF-025 (Other Identifier)

WB29908

Details and patient eligibility

About

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.

Enrollment: 1,009 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

1,009 participants in 1 patient group

Pirfenidone

Description:

Participants will receive pirfenidone orally according to the physician discretion.

Treatment:

Drug: Pirfenidone