Conditions: Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis
Keywords: pulmonary fibrosis respiratory diseases
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 83
Healthy volunteers: no

Brief 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.

Arms:
arm 1: up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study

Interventions: intervention 1: Pirfenidone
Intervention descriptions: intervention 1: up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study

Protocol document: