Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo 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 ≥ 50% predicted value

• carbon monoxide diffusing capacity (DLco) ≥ 35% predicted value

• either Forced Vital Capacity or carbon monoxide diffusing capacity (DLco) ≤ 90% predicted value

• no improvement in past year

• able to walk 150 meters in 6 minutes and maintain saturation ≥ 83% while on no more than 6 liters per minute supplemental oxygen

Primary Exclusion criteria:

• unable to undergo pulmonary function testing

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

• in the clinical opinion of the investigator, the patient is expected to need and be eligible for a lung transplant within 72 weeks of 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 syndrome

• other IPF treatment

• unable to take study medication

• withdrawal from other IPF trials