Status:
COMPLETED
Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Texas Tech University Health Sciences Center
Collaborating Sponsors:
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Conditions:
Respiratory Tract Diseases
Lung Diseases
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the possible efficacy of low dose, orally administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF).
Detailed Description
This is a pilot study to determine if oral administration of low doses of Interferon alpha might be effective in treating Idiopathic Pulmonary Fibrosis (IPF). This is a disease that damages the lungs ...
Eligibility Criteria
Inclusion
- The only subjects to be included in this study are those diagnosed with Idiopathic Pulmonary Fibrosis with diagnosis based on the criteria published by the American Thoracic Society in the International Consensus Statement.
- Exclusion of other known causes of interstitial lung disease.
- Abnormal pulmonary function studies.
- Bibasilar reticular abnormalities with minimal ground glass opacities on HRCT scan.
- Biopsy or lavage showing no features supporting alternative diagnosis.
- Patient older than 50 years of age.
- Insidious onset of otherwise unexplained dyspnea on exertion.
- Duration greater than 3 months.
- Bibasilar, inspiratory crackles.
Exclusion
- under the age of 50
- history of hypersensitivity to interferons
- history of hypersensitivity to biological products such as vaccines
- pregnant or lactating women
- women of child bearing age not pregnancy protected during the study
- unresolved serious cardiovascular disease
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01442779
Start Date
September 1 2000
End Date
May 1 2007
Last Update
April 20 2012
Active Locations (1)
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1
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430