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

Completed · Phase 3

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID

NCT00662038

Run by

Genentech, Inc.

People needed

1058

Starts

2008-08-01

Expected to finish

2016-02-01

Last updated by the study team

2017-03-29

Who can join

Age: 40 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Genentech, Inc. — South San Francisco, California, United States

Full record on ClinicalTrials.gov

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