A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis

Completed · Phase 1

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind, placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011. Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in subjects with IPF and is currently enrolling.

Key facts

Study ID

NCT01362231

Run by

Gilead Sciences

People needed

48

Starts

2010-12-01

Expected to finish

2012-12-01

Last updated by the study team

2015-07-09

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acceptable results on pulmonary function tests
• At rest oxygen saturation ≥90% on room air
• Adequate organ function

You may not qualify if…

• High resolution computer tomography pattern showing emphysema that is greater than fibrosis
• Acceptable results on whole body plethysmography
• History of clinically significant hepatic or renal disease
• Poorly controlled or severe diabetes mellitus
• Use of systemic immunosuppressants within 28 days of GS-6624 infusion

Where it is running

• Arizona Pulmonary Specialists — Scottsdale, Arizona, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Loess Hills Clinical Research Center — Council Bluffs, Iowa, United States
• UPMC Translational Research Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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