Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

• Status: Completed
• Trial end date: 2008-11-10
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.

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

Details

• Lead Sponsor: Genentech, Inc.; InterMune
• Treatments: Pirfenidone

Criteria

Primary Inclusion criteria:

• diagnosis of idiopathic pulmonary fibrosis

• 40 to 80 years of age

• Forced Vital Capacity greater than or equal to 50% predicted value

• Carbon monoxide diffusing capacity greater than or equal to 35% predicted value

• either Forced Vital Capacity or Carbon monoxide diffusing capacity less than or equal to 90% predicted value

• no improvement in past year

• able to walk 150 meters in 6 minutes and maintain saturation greater than or equal to 83% while on no more than 6 liters per minute (L/min) supplemental oxygen

Primary Exclusion criteria:

• unable to undergo pulmonary function testing

• evidence of significant obstructive lung disease or airway hyper-responsiveness

• in opinion of investigator patient is expected to need and be eligible for a lung transplant within 72 weeks after randomization

• active infection

• liver disease

• cancer or other medical condition likely to result in death within 2 years

• diabetes

• pregnancy or lactation

• substance abuse

• personal or family history of long QT (Q wave,T wave) syndrome

• other IPF treatment

• unable to take study medication

• withdrawal from other IPF trials