Status:
TERMINATED
Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.
Eligibility Criteria
Inclusion
- Inclusion criteria
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF), based on an appropriate clinical definition of IPF as detailed in the ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management Diagnosis must be confirmed by a diagnostic HRCT or surgical lung biopsy.
- A 6-minute walk test (6MWT) distance ≥50 meters at Screening (use of supplemental oxygen allowed).
- Exclusion criteria
- Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine levels in the range defined as 'smokers' per the local lab.
- Lung residual volume \> 120% predicted at Screening.
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01266135
Start Date
December 1 2010
End Date
April 1 2013
Last Update
December 19 2020
Active Locations (10)
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1
Novartis Investigative Site
Gainesville, Florida, United States, 32611
2
Novartis Investigative Site
Orlando, Florida, United States, 32803
3
Novartis Investigative Site
Boston, Massachusetts, United States, 02115
4
Novartis Investigative Site
Durham, North Carolina, United States, 27710