Full Text View
Tabular View
No Study Results Posted
Related Studies
Safety and Tolerability Study of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis
This study has been completed.
Study NCT00074698   Information provided by FibroGen
First Received: December 18, 2003   Last Updated: December 10, 2007   History of Changes

December 18, 2003
December 10, 2007
 
 
 
 
Complete list of historical versions of study NCT00074698 on ClinicalTrials.gov Archive Site
 
 
 
Safety and Tolerability Study of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis

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.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Idiopathic Pulmonary Fibrosis
Drug: FG-3019
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
27
May 2004
 

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)
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00074698
 
FGCL-MC3019-002
FibroGen
 
 
FibroGen
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP