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
PurposeA double blind, randomized, placebo-controlled trial evaluating the effect of oral Pirfenidone on the rate of decline of FVC (forced vital capacity) in patients with IPF. Results from 4 previous controlled trials suggest that Pirfenidone treatment is safe and well tolerated and results in clinically meaningful benefits in a variety of domains, including lung volume, exercise tolerance, and progression-free survival time in patients with IPF. Given the primacy of loss of lung volumes over time in patients with IPF, this protocol is intended to confirm that Pirfenidone 2403 mg/d reduces decline in FVC over 52 weeks compared with placebo in patients with IPF.
- 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