An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) who complete the CAPACITY Studies.
CONCISE SUMMARY OF PROJECT: Only sites that participated in the PIPF 004 CAPACITY study will be eligible to participate in the study. This is a single treatment arm (pirfenidone 2403 mg/d) open-label study design. Approximately 750 patients across approximately 110 centers in 11 countries globally will receive pirfenidone 2403 mg/d in divided doses, three times a day. The primary objective is to obtain additional safety date for pirfenidone 2403 mg/d. Secondary objectives are to obtain additional efficacy data for pirfenidone 2403 mg/d and provide access to pirfenidone to qualifying patients who complete the PIPF-004 or PIPF-006 (not being conducted at UTSW) studies. Enrollment into this study will begin as CAPACITY (PIPF 004) subjects complete their Final Follow-Up Visits and will continue until approximately 10 days after the last subject randomized in the CAPACITY study would have completed his/her final study visit.
The duration of treatment for each patient will continue until pirfenidone is commercially available in a geographic region, the study is terminated by the sponsor.
1. Completes the qualifying clinical study final visit.
2. In the opinion of the 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
3. Is able to provide informed consent and comply with the requirements of the study