Phase 3
N=1,058
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00662038 ↗Enrolled (actual)
1,058
Serious AEs
54.0%
Results posted
Mar 2017
Primary outcome: Primary: Percentage of Participants With Adverse Events — 98.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pirfenidone (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
98.0 | — |
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 data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00662038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.