Overview

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