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Home > "S" Clinical Trials Conditions > Safety and Tolerability Study of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis  Safety and Tolerability Study of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis
Safety and Tolerability Study of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis
For Condition: Idiopathic Pulmonary Fibrosis
Status: Completed
Sponsor(s): FibroGen, Inc. ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 21 Years/80 Years
Genders: Both
Protocol Entry 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)
Total Enrollment: 27
Location and Contact Information:
Southwestern Medical School
Dallas, Texas, 75390
United States
National Jewish Medical and Research Center
Denver, Colorado, 80206
United States
University of Michigan Health Sciences
Ann Arbor, Michigan, 48109
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States
Additional Information:
Study ID Numbers: FGCL-MC3019-002;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074698
Other Idiopathic Pulmonary Fibrosis Studies:
1. The INSPIRE Trial: A Study of Interferon gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)
2. A Study of the Safety and Clinical Effects of Interferon gamma-1b in Patients with Idiopathic Pulmonary Fibrosis (IPF)
3. Safety and Tolerability Study of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis
4. Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF)
5. An Open-Label Study of the Safety of Interferon gamma-1b in Patients with IPF
Related Studies:
Other Idiopathic Pulmonary Fibrosis Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Safety and Tolerability Study of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis
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