Status:
COMPLETED
Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
FibroGen
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
21-80 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FG-3019, a therapeutic antibody designed to block the pro-fibrotic activity of connectiv...
Eligibility Criteria
Inclusion
- Key
- have a diagnosis of idiopathic pulmonary fibrosis (IPF) by clinical features and surgical lung biopsy or according to the American Thoracic Society criteria
- Key
Exclusion
- have a history of significant exposure to organic or inorganic dust or drugs known to cause pulmonary fibrosis
- 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)
- Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
December 8 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00074698
Start Date
December 8 2003
End Date
May 1 2004
Last Update
July 12 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
2
University of Michigan Health Sciences
Ann Arbor, Michigan, United States, 48109
3
Southwestern Medical School
Dallas, Texas, United States, 75390
4
University of Washington Medical Center
Seattle, Washington, United States, 98195