Status:
COMPLETED
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Genentech, Inc.
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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 (IP...
Detailed Description
This is a Phase 3, randomized, double blind, placebo-controlled, three-arm, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis. Approximately 400 patients at appro...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 14 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2008
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT00287716
Start Date
July 14 2006
End Date
November 10 2008
Last Update
May 22 2017
Active Locations (1)
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1
InterMune, Inc.
Brisbane, California, United States, 94005