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

This study has been completed.
Sponsor:
Information provided by:
FibroGen
ClinicalTrials.gov Identifier:
NCT00074698
First received: December 18, 2003
Last updated: December 10, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00074698     History of Changes
Other Study ID Numbers: FGCL-MC3019-002
Study First Received: December 18, 2003
Last Updated: December 10, 2007
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014