Status:
COMPLETED
Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Genentech, Inc.
Conditions:
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief Summary
To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).
Detailed Description
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 pirfenido...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 31 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2015
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00080223
Start Date
August 31 2003
End Date
April 30 2015
Last Update
April 17 2017
Active Locations (27)
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1
Phoenix, Arizona, United States, 85006
2
Pomona, California, United States, 91767
3
San Jose, California, United States, 95119
4
New Haven, Connecticut, United States, 06520