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Sponsored by: |
FibroGen |
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Information provided by: | FibroGen |
ClinicalTrials.gov Identifier: | NCT00074698 |
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 |
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Idiopathic Pulmonary Fibrosis |
Drug: FG-3019 |
Phase I |
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 |
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | FGCL-MC3019-002 |
Study First Received: | December 18, 2003 |
Last Updated: | December 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00074698 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Idiopathic pulmonary fibrosis IPF Pulmonary fibrosis Respiratory disease |
Lung Diseases, Interstitial Respiratory Tract Diseases Fibrosis Idiopathic Pulmonary Fibrosis |
Lung Diseases Respiration Disorders Pulmonary Fibrosis |
Lung Diseases, Interstitial Pathologic Processes Respiratory Tract Diseases |
Fibrosis Lung Diseases Pulmonary Fibrosis |