|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00532233 |
|
Date of registration:
|
19/09/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
SD, IL-13 Production Rate in IPF
|
|
Scientific title:
|
A Open-label, Multicenter Study, With a Single Intravenous Dose of QAX576 to Determine IL-13 Production in Patients With Idiopathic Pulmonary Fibrosis |
|
Date of first enrolment:
|
September 2007 |
|
Target sample size:
|
52 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00532233 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Novartis |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Investigative site |
|
|
Name:
|
Novartis Pharmaceuticals |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novartis Pharmaceuticals |
| |
|
Key inclusion & exclusion 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
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Idiopathic Pulmonary Fibrosis
|
|
Intervention(s)
|
|
Drug: QAX576
|
|
Primary Outcome(s)
|
|
-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(s)
|
|
-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]
|
|
Secondary ID(s)
|
|
CQAX576A2202
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|