Research Studies

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   

Purpose

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.

Inclusion Criteria

Factors that allow someone to participate in a clinical trial.
  • 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

Exclusion Criteria

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