Safety and Tolerability Study of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis - Full Text View

Purpose

The purpose of this study is to evaluate the safety and tolerability of FG-3019, a therapeutic antibody designed to block the pro-fibrotic activity of connective tissue growth factor (CTGF). CTGF triggers the production of collagen and fibronectin, which cause scarring and thickening of the lungs. Approximately 18 to 27 males and females, 21 to 80 years of age with a diagnosis of idiopathic pulmonary fibrosis (IPF) will be enrolled in this study. The duration of the study is approximately one month, during which patients will receive a single infusion of FG-3019. In addition, there will be two follow-up visits 6 and 12 months after receiving the study drug.

Condition	Intervention	Phase
Idiopathic Pulmonary Fibrosis	Drug: FG-3019	Phase I

MedlinePlus related topics:

Pulmonary Fibrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis

Further study details as provided by FibroGen:

Estimated Enrollment:	27
Estimated Study Completion Date:	May 2004

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

are 21 to 80 years of age
have a diagnosis of IPF by surgical lung biopsy or according to the American Thoracic Society criteria

Exclusion Criteria:

have a history of significant exposure to organic or inorganic dust or drugs known to cause IPF
have interstitial lung disease other than IPF
have pulmonary fibrosis associated with connective tissue disease
have other forms of idiopathic interstitial pneumonia, such as desquamative interstitial pneumonia, acute interstitial pneumonia, nonspecific interstitial pneumonia, or cryptogenic organizing pneumonia
have end-stage IPF (total lung capacity of less than 45% of predicted value)
are listed for lung transplantation at the time of study enrollment
have significant heart problems
are pregnant or lactating (if female)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074698

Locations


United States, Colorado
	National Jewish Medical and Research Center
	Denver, Colorado, United States, 80206

United States, Michigan
	University of Michigan Health Sciences
	Ann Arbor, Michigan, United States, 48109

United States, Texas
	Southwestern Medical School
	Dallas, Texas, United States, 75390

United States, Washington
	University of Washington Medical Center
	Seattle, Washington, United States, 98195

Sponsors and Collaborators

FibroGen

More Information

Study ID Numbers:	FGCL-MC3019-002
First Received:	December 18, 2003
Last Updated:	December 10, 2007
ClinicalTrials.gov Identifier:	NCT00074698
Health Authority:	United States: Food and Drug Administration

Keywords provided by FibroGen:

Idiopathic pulmonary fibrosis

IPF

Pulmonary fibrosis

Respiratory disease

Study placed in the following topic categories:

Lung Diseases, Interstitial

Respiratory Tract Diseases

Fibrosis

Hamman-Rich syndrome

Lung Diseases

Respiration Disorders

Fibrosing alveolitis

Pulmonary Fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	FibroGen
Information provided by:	FibroGen
ClinicalTrials.gov Identifier:	NCT00074698