An Open-label Phase II Study of the Safety of Oral Pirfenidone in Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
Subjects who participated in a previous InterMune IPF study were allowed to enroll under the initial protocol version. A prior modification (Amendment 2) limited invitation to participate to those selected through the Early Access Program (EAP). New enrollment of subjects is now closed. Study participation will last until the drug has been FDA approved and is commercially available, or until terminated by Intermune.
Patients were transitioned from 400 mg capsules to 267 mg capsules with Amendment 3 and continue dosing up to a maximum of 3600 mg per day. Study medication will be taken with food, at the same times each day (or with milk or juice other than grapefruit juice if the patient is unable to eat).
Evaluations occur every 12 weeks. A pregnancy test and blood (2 tablespoons) is drawn every 12 weeks, pulmonary function tests performed every 24 weeks. These procedures are considered standard of care. Patients will be asked to bring all study medication with them to each visit. All medication is counted at each study visit to ensure compliance in dosing.
Enrollment of new subjects is closed. Inclusion criteria included:
Selection through the EAP and enrollment at a regional center approved by InterMune.
Willing to travel to an approved regional center for study related visits.
Diagnosis-related inclusion criteria includes clinical symptoms consistent with IPF of >=3 months duration
Age 40-85 years
Predicted FVC of >=45% and a percent predicted DLco of >=30% at the time of enrollment into the study.