Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
Centocor, Inc.
Conditions:
Pulmonary Fibrosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The experimental drug CNTO 888 is currently being studied in cancer patients with solid tumors and this study is the first to use this drug for patients with idiopathic pulmonary fibrosis (IPF). This ...
Detailed Description
This study tests the safety and effectiveness of an experimental drug, CNTO 888, compared to placebo. The purpose of this research study is to determine if CNTO 888 is safe and to determine its effect...
Eligibility Criteria
Inclusion
- Forced Vital Capacity (FVC) \>= (greater than or equal to) 50% of the predicted value at screening
- Abnormal lung function test results that include evidence of restriction and impaired gas exchange, or evidence of desaturation at rest or exercise or decreased diffusing capacity of the lung for carbon monoxide (DLCO)
- Bibasilar reticular abnormalities with minimal ground-glass opacities on high-resolution computed tomography (HRCT) scans
- Have surgical lung biopsy evidence of usual interstitial pneumonia (UIP) and/or HRCT scan-based diagnosis of IPF
- Relative decrease of \>= 10% in forced vital capacity (FVC), or relative decrease of \>= 15% in DLCO, or evidence of clinically significant worsening on HRCT (eg, development of honeycombing, increase in opacities), or significant worsening of dyspnea at rest or with exertion.
Exclusion
- Have evidence of interstitial pneumonia other than IPF
- Diagnosis of IPF is not confirmed by HRCT or lung biopsy results
- Partial pressure of oxygen in arterial blood (PaO2) \< 55 mmHg (sea level) or 50 mmHg (altitude) at rest on room air
- Have a diagnosis of other significant respiratory disorder (eg, asthma, tuberculosis (TB), sarcoidosis, aspergillosis, chronic obstructive pulmonary disease \[COPD\], or cystic fibrosis)
- Have obstruction on prebronchodilator pulmonary function tests (PFTs) (defined as FEV1/FVC \< 0.7) at screening or demonstrate an increase in FEV1 \>= 12% postbronchodilator.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00786201
Start Date
December 1 2008
End Date
January 1 2012
Last Update
December 28 2015
Active Locations (30)
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1
Birmingham, Alabama, United States
2
Phoenix, Arizona, United States
3
Miami, Florida, United States
4
Tampa, Florida, United States