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

NCT02699879 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1009

Last updated 2017-04-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Pirfenidone

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-16
Primary Completion
2016-09-15
Completion
2016-09-15

Countries

  • Austria
  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Norway
  • Sweden
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02699879 on ClinicalTrials.gov