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SD, IL-13 Production Rate in IPF

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: September 19, 2007
Last updated: June 20, 2017
Last verified: June 2017
The purpose of this study is to investigate how QAX576 affects levels of interleukin 13 (IL-13) in patients with idiopathic pulmonary fibrosis (IPF).

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis Drug: QAX576 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Open-label, Multicenter Study, With a Single Intravenous Dose of QAX576 to Determine IL-13 Production in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • -To investigate the possibility that some IPF patients experience increased IL-13 production. Blood samples to be collected pre-dose and weekly after dosing. -To investigate the hypothesis that QAX576 will neutralize IL-13 in patients with IPF [ Time Frame: Week 1,2,3 and 4 ]

Secondary Outcome Measures:
  • -To evaluate the changes in biomarkers in blood over time in patients with IPF. Serum samples will be obtained at pre-dose and 2 weeks post-dose. [ Time Frame: Week 3 ]

Enrollment: 52
Study Start Date: September 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: QAX576


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women between the ages of 40 and 80 years with a confirmed diagnosis of idiopathic pulmonary fibrosis
  • Both men and women must be on non-childbearing potential. Additional information regarding this requirement is available at screening.
  • Capability to meet certain lung function tests at screening
  • Non-smokers
  • No participation in another clinical study within 4 weeks of study start.

Exclusion Criteria:

  • Certain medical conditions may exclude candidates from participation.
  • Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
  • Past medical personal or close family history of clinically significant ECG abnormalities
  • Connective tissue disorders
  • Active infection or history of systemic parasitic infection
  • Known hypersensitivity to the drug.
  • History of immunocompromise, including a positive HIV test result.
  • History of drug or alcohol abuse within 12 months of study start
  • Any condition that may compromise patient safety
  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 identifier: NCT00532233

United States, Colorado
Novartis Investigative Site
Denver, Colorado, United States, 80206
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30319
United States, Louisiana
Novartis Investigative Site
New Orleans, Louisiana, United States, 70112
United States, Minnesota
Novartis Investigative Site
Rochester, Minnesota, United States, 55905
United States, North Carolina
Novartis Investigative Site
Durham, North Carolina, United States, 27704
United States, Pennsylvania
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Novartis Investigative site
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00532233     History of Changes
Obsolete Identifiers: NCT00843999
Other Study ID Numbers: CQAX576A2202
Study First Received: September 19, 2007
Last Updated: June 20, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Idiopathic Pulmonary Fibrosis

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial processed this record on September 21, 2017