Phase 3
Completed N=1,058
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Source: ClinicalTrials.gov NCT00662038 ↗Enrolled (actual)
1,058
Serious AEs
54.0%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants With Adverse Events — 98.0 percentage of participants
◆ Published Evidence
Highly cited
151citations · ~17 / year
An Open-Label Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (RECAP).
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.
Linked Publications (4)
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An Open-Label Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (RECAP).
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Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials.
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Pirfenidone Treatment in Individuals with Idiopathic Pulmonary Fibrosis: Impact of Timing of Treatment Initiation.
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Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
98.0 | — |
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) and the linked publication. 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. Informational only — not medical advice.