Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
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Brief Summary
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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.

Detailed Description
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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 qualifying study, have not permanently discontinued study drug in their qualifying study, and meet all of the eligibility criteria noted in this protocol. Since data from the qualifying study may remain blinded during patient enrollment in PIPF-012, all patients will be treated as if they were taking placebo in their qualifying study. At the start of PIPF-012 participation, each patient will escalate the dose of pirfenidone. The duration of treatment for each patient will vary and will continue until pirfenidone is commercially or otherwise available in his/her geographic region or the study is terminated by the sponsor for reasons outlined in the protocol.

Official Title
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An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: pirfenidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>pirfenidone | Drug: pirfenidone<br>* Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events | An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause. | 7.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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idiopathic, pulmonary, fibrosis