Phase 2
N=83
Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis · Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00080223 ↗Enrolled (actual)
83
Serious AEs
59.0%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE — 98.8; 59.0; 36.1; 21.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pirfenidone (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE |
98.8; 59.0; 36.1; 21.7; 25.3; 43.4 | — |
| SECONDARY Percent Predicted Forced Vital Capacity (FVC) |
67.7; 67.5; 68.7; 68.4; 67.9; 67.7 | — |
| SECONDARY Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco) |
38.0; 39.5; 37.1; 37.0; 38.0; 35.7 | — |
| SECONDARY Resting Oxygen Saturation by Pulse Oximetry (SpO2) |
94.5; 94.4; 94.8; 94.9; 94.9; 94.8 | — |
| SECONDARY Overall Survival |
508.7 | — |
Summary
To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00080223). 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.