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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1058 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2016-02-29

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.

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

pirfenidone

Group Type EXPERIMENTAL

pirfenidone

Intervention Type DRUG

Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.

Interventions

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pirfenidone

Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.

Intervention Type DRUG

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No