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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00532233 |
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 II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | An Open-Label, Multi-Center Study, With a Single Intravenous Dose of QAX576 to Determine IL-13 Production in Patients With Idiopathic Pulmonary Fibrosis |
Estimated Enrollment: | 50 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
QAX576
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Drug: QAX576 |
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Novartis | 862-778-8300 |
United States, Colorado | |
Novartis Investigator Site | Recruiting |
Denver, Colorado, United States, 80206-2761 | |
Contact: Novartis Investigator Site 303-270-2053 | |
United States, Georgia | |
Novartis Investigator Site | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Novartis Investigator Site 404-727-6552 | |
Contact: Novartis Investigator Site 404-727-2974 | |
United States, Louisiana | |
Novartis Investigator Site | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Novartis 862-778-8300 | |
United States, Minnesota | |
Novartis Investigator Site | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Novartis Investigator Site 507-284-9187 | |
Contact: Novartis Investigator Site 507-266-1026 | |
United States, North Carolina | |
Novartis Investigator Site | Recruiting |
Durham, North Carolina, United States, 27717 | |
Contact: Novartis Investigator Site 919-668-4562 | |
United States, Pennsylvania | |
Novartis Investigator Site | Recruiting |
Pittsburg, Pennsylvania, United States, 15213 | |
Contact: Novartis Investigator Site 412-647-4537 |
Principal Investigator: | Novartis | Investigative site |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CQAX576A2202 |
Study First Received: | September 19, 2007 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00532233 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Idiopathic Pulmonary Fibrosis |
Lung Diseases, Interstitial Respiratory Tract Diseases Fibrosis |
Idiopathic Pulmonary Fibrosis Lung Diseases Pulmonary Fibrosis |
Lung Diseases, Interstitial Pathologic Processes Respiratory Tract Diseases |
Fibrosis Lung Diseases Pulmonary Fibrosis |