NCT00080223

Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

An Open-Label, Phase 2 Study of the Safety of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).

Detailed description

This study has been designed as a rollover study to collectively include safety data from various previous studies. In addition, InterMune has also initiated an Early Access Program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the United States. This program is also being conducted under this protocol. Registration of patients with documented IPF has been closed as of October 2005.

Conditions

• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Pirfenidone	up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study

Timeline

• Start date: 2003-08-31
• Primary completion: 2015-04-30
• Completion: 2015-04-30
• First posted: 2004-03-26
• Last updated: 2017-04-17
• Results posted: 2016-03-09

Locations

27 sites across 1 country: United States