Completed

An Open-Label, Phase 2 Study of the Safety of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

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What is being tested

Pirfenidone

Drug
Who is being recruted

Fibrosis+4

+ Lung Diseases

+ Pathologic Processes

From 40 to 85 Years
See all eligibility criteria
How is the trial designed

Other Study

Phase 2
Interventional
Study Start: August 2003
See protocol details

Summary

Principal SponsorGenentech, Inc.
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 31, 2003

Actual date on which the first participant was enrolled.

This study has been designed as a rollover study to collectively include safety data from various previous studies. In addition, InterMune has also initiated an Early Access Program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the United States. This program is also being conducted under this protocol. Registration of patients with documented IPF has been closed as of October 2005.

Official TitleAn Open-Label, Phase 2 Study of the Safety of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis 
NCT00080223
Principal SponsorGenentech, Inc.
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

83 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FibrosisLung DiseasesPathologic ProcessesPulmonary FibrosisRespiratory Tract DiseasesLung Diseases, InterstitialIdiopathic Pulmonary Fibrosis

Criteria

General Inclusion Criteria: * Able to understand and sign an informed consent form * Understand the importance of adherence to study treatment and the study protocol, including concomitant medication restrictions, throughout the study period * Patients must be willing to travel to an approved regional center for all study-related visits Roll-Over Criteria: * Entry into study through rollover has been completed Criteria for Early Access Program patients: * Clinical symptoms consistent with IPF ≥3 months duration * Age 40 - 85, inclusive * At the time of registration with National Organization for Rare Disorders (NORD), patients with IPF must have a percent predicted forced vital capacity (FVC) of ≥50%, and percent predicted carbon monoxide diffusing capacity (DLCO) of ≥35% * At the time of enrollment in PIPF-002, (screening/baseline visit) percent predicted FVC must be ≥45%, and percent predicted DLCO must be ≥30% * High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients with surgical lung biopsy showing definite or probable usual interstitial pneumonia (UIP), the HRCT criterion of probable IPF is sufficient * For patients aged \<50 years: open or video-assisted thoracoscopic (VATS) lung biopsy showing definite or probable UIP. In addition, no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage if performed * For patients aged ≥50 years: at least one of the following diagnostic findings as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis: 1) Open or VATS lung biopsy showing definite or probable UIP; 2) Transbronchial biopsy showing no features to support an alternative diagnosis; 3) Bronchoalveolar lavage (BAL) showing no features to support an alternative diagnosis

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers