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SD, IL-13 Production Rate in IPF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00532233
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE September 19, 2007
First Posted Date  ICMJE September 20, 2007
Last Update Posted Date December 19, 2020
Study Start Date  ICMJE September 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2009)
-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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2007)
-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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2009)
-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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2007)
-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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SD, IL-13 Production Rate in IPF
Official Title  ICMJE A Open-label, Multicenter Study, With a Single Intravenous Dose of QAX576 to Determine IL-13 Production in Patients With Idiopathic Pulmonary Fibrosis
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE Drug: QAX576
Study Arms  ICMJE Experimental: 1
QAX576
Intervention: Drug: QAX576
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2012)
52
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2007)
50
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00532233
Other Study ID Numbers  ICMJE CQAX576A2202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Novartis Investigative site
PRS Account Novartis
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP