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NCT00532233 Clinical Trial

SD, IL-13 Production Rate in IPF

Idiopathic Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00532233
Other study ID # CQAX576A2202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2007
Est. completion date June 2009

Study information
Verified date June 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate how QAX576 affects levels of interleukin 13 (IL-13) in patients with idiopathic pulmonary fibrosis (IPF).

Other known NCT identifiers
  • NCT00843999

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• QAX576

Locations
Country Name City State
United States Novartis Investigative Site Atlanta Georgia
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Durham North Carolina
United States Novartis Investigative Site New Orleans Louisiana
United States Novartis Investigative Site Pittsburgh Pennsylvania
United States Novartis Investigative Site Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary -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 Week 1,2,3 and 4
Secondary -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. Week 3
See also
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Active, not recruiting NCT02951416 - Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
Terminated NCT00981747 - Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis Phase 2/Phase 3
Completed NCT00540475 - Pennsylvania Idiopathic Pulmonary Fibrosis Research Registry
Recruiting NCT00470327 - A Study of the Natural Progression of Interstitial Lung Disease (ILD)

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