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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00074698
First Posted: December 22, 2003
Last Update Posted: December 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
FibroGen
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by FibroGen:

Estimated Enrollment: 27
Estimated Study Completion Date: May 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00074698     History of Changes
Other Study ID Numbers: FGCL-MC3019-002
First Submitted: December 18, 2003
First Posted: December 22, 2003
Last Update Posted: December 12, 2007
Last Verified: December 2007

Keywords provided by FibroGen:
Idiopathic pulmonary fibrosis
IPF
Pulmonary fibrosis
Respiratory disease

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial