Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Collaborator: Hoffmann-La Roche
• Treatments: Pirfenidone

Criteria

Inclusion Criteria:

• Completes the qualifying clinical study final visit

• In the opinion of the principal investigator (PI), has been generally compliant with study requirements during the qualifying study, or must be considered eligible to enroll in PIPF-012 by the InterMune medical monitor

• Is able to provide informed consent and comply with the requirements of the study

Exclusion Criteria:

• Is pregnant or lactating

• Has known hypersensitivity to any of the components of the study drug

• Starts participation in another interventional clinical trial between the end of participation in the qualifying InterMune clinical trial and entry into PIPF-012

• Receives concomitant and/or excluded medications as defined in the protocol

• Permanently discontinues study drug during the qualifying study for any reason before study completion