PIPF 016 (Intermune): A Randomized, Double Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis.
Status: Active - Enrolling.
PI: Danielle Antin-Ozeris, M.D.
Contact: Jean Estrom (203) 785-7324
- Diagnosis of definite or probable Idiopathic Pulmonary Fibrosis (IPF) per the ATS 2011 Guidelines up to 48 months before randomization
- Age 40 to 80 at randomization
- Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening
- Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening
Factors that do not allow someone to participate in a clinical trial.
- Forced expiratory volume in one second (FEV1)/FVC ratio <0.8 after administration of bronchodilator at Screening
- Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
- Known explanation for interstitial lung disease
- History of asthma or chronic obstructive pulmonary disease
- Active infection
- Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
- History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months