Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/30/2013 |
| Start Date: | December 2010 |
| End Date: | October 2013 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | +1(862)778-8300 |
Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF
This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy
of QAX576 in patients with idiopathic pulmonary fibrosis.
Inclusion Criteria:
- Diagnosis of Idiopathic Pulmonary Fibrosis.
- A 6-minute walk test (6MWT) distance ≥50 meters at Screening (use of supplemental
oxygen allowed)
Exclusion Criteria:
- Smokers
- Forced Expiratory Volume in One Second/Forced Vital Capacity ratio < 0.6 at screening
(pre or post-bronchodilator)
- Lung residual volume > 120% predicted at Screening
- High-Resolution Computed Tomography (HRCT) showing only ground glass infiltrates
without other typical features of pulmonary fibrosis
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
7
sites
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