Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Tech University Health Sciences Center
• Collaborator: Amarillo Biosciences, Inc.
• Treatments: Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

• 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.

1. Exclusion of other known causes of interstitial lung disease.

2. Abnormal pulmonary function studies.

3. Bibasilar reticular abnormalities with minimal ground glass opacities on HRCT scan.

4. Biopsy or lavage showing no features supporting alternative diagnosis.

5. Patient older than 50 years of age.

6. Insidious onset of otherwise unexplained dyspnea on exertion.

7. Duration greater than 3 months.

8. Bibasilar, inspiratory crackles.

Exclusion Criteria:

• 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