Clinical Study With QAX576 in Patients With Idiopathic Pulmonary Fibrosis - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00532233

Purpose

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

MedlinePlus related topics: Pulmonary Fibrosis

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

Further study details as provided by Novartis:

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

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.

Estimated Enrollment:	50
Study Start Date:	October 2007
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental QAX576	Drug: QAX576

Eligibility

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532233

Contacts

Contact: Novartis

862-778-8300

Locations

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

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Investigative site

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQAX576A2202
Study First Received:	September 19, 2007
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00532233
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Idiopathic Pulmonary Fibrosis

Study placed in the following topic categories:

Lung Diseases, Interstitial
Respiratory Tract Diseases
Fibrosis

Hamman-Rich syndrome
Lung Diseases
Pulmonary Fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009