Status:
COMPLETED
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-84 years
Phase:
PHASE3
Brief Summary
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety d...
Detailed Description
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. Eligible patients must complete the final visit for their ...
Eligibility Criteria
Inclusion
- Completes the qualifying clinical study final visit
- In the opinion of the principal investigator (PI), has been generally compliant with study requirements during the qualifying study, or must be considered eligible to enroll in PIPF-012 by the InterMune medical monitor
- Is able to provide informed consent and comply with the requirements of the study
Exclusion
- Is pregnant or lactating
- Has known hypersensitivity to any of the components of the study drug
- Starts participation in another interventional clinical trial between the end of participation in the qualifying InterMune clinical trial and entry into PIPF-012
- Receives concomitant and/or excluded medications as defined in the protocol
- Permanently discontinues study drug during the qualifying study for any reason before study completion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
1058 Patients enrolled
Trial Details
Trial ID
NCT00662038
Start Date
August 1 2008
End Date
February 1 2016
Last Update
March 29 2017
Active Locations (1)
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1
Genentech, Inc.
South San Francisco, California, United States, 94080-4990