Interstitial Lung Disease
- PIPF 016: A Randomized, Double Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis
A 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.
PI: Nina Patel, MD
Contact:
Patricia Jellen (212) 305-1158
Jaya Tiwari (212) 342-1518
Nisha Philip (212) 305-7720 - BIBF 1120: A 52 Week, Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, On Annual Forced Vital Capacity Decline, In Patients with Idiopathic Pulmonary Fibrosis (IPF)
A double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, on annual decline in FVC in patients with IPF. The study drug, called BIBF 1120, is a small molecule antifibrotic kinase inhibitor (PDGF/R [platelet derived growth factor/receptor], FGF/R [fibroblast growth factor/receptor], VEGF/R [vascular endothelial growth factor/receptor]) being developed for the treatment of IPF. Theoretical and pharmacological models suggest that inhibition of these kinase receptors may interfere with the fibrotic signaling cascade. BIBF 1120 has been studied in a large Phase 2 trial in patients with IPF. In this first study the drug has shown promising effects in reducing the rate of decline of FVC and reducing exacerbation, as well as several other endpoints.
PI: David Lederer, MD, MS
Contact:
Patricia Jellen (212) 305-1158
Jaya Tiwari (212) 342-1518
Nisha Philip (212) 305-7720 - A Phase One, Open Label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Biologic Effects of Three Doses of IW001 in Patients with Idiopathic Pulmonary Fibrosis (IPF)
Contact:
Jaya Tiwari (212) 342-1518 - An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies
PI: Nina Patel, MD
Contact:
Pat Jellen (212) 305-1158
Not recruiting; roll over study
622 West 168 Street | PH 8 East, Room 101
