Status:
COMPLETED
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 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 ...
Detailed Description
This is a Phase 3, randomized, double-blind, placebo-controlled, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). Approximately 320 patients at approximat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00287729
Start Date
April 1 2006
End Date
November 1 2008
Last Update
April 17 2017
Active Locations (1)
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1
InterMune, Inc.
Brisbane, California, United States, 94005