PIPF-012 (InterMune): An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF).
Status: Active - Enrolling.
PI: Danielle Antin-Ozeris, M.D.
Contact: Jean Estrom (203) 785-7324
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.
- Completes the qualifying clinical study final visit
- In the opinion of the principal investigator (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
- Is able to provide informed consent and comply with the requirements of the study
Factors that do not allow someone to participate in a clinical trial.
- Is pregnant or lactating
- Has known hypersensitivity to any of the components of the study drug
- Starts participation in another interventional clinical trial between the end of participation in the qualifying InterMune clinical trial and entry into PIPF-012
- Receives concomitant and/or excluded medications as defined in the protocol
- Permanently discontinues study drug during the qualifying study for any reason before study completion