Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02151435
• Date of registration: 28/05/2014
• Prospective Registration: No
• Primary sponsor: University of Michigan
• Public title: Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis
• Scientific title: Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis
• Date of first enrolment: August 2013
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02151435
• Study type: Observational
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Eric S White, MD
• Affiliation: University of Michigan

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 35-80 years, inclusive

2. Diagnosis of IPF by HRCT or surgical lung biopsy

3. Able to understand and provide informed consent

Exclusion Criteria:

1. AE-IPF during the prior year

2. Environmental exposure (occupational, drug, etc.) felt to be the etiology of the
interstitial disease.

3. Diagnosis of collagen-vascular conditions according to published American College of
Rheumatology criteria.

4. Significant airway obstruction (FEV1/FVC ratio < 0.60) or bronchodilator response,
defined as a change in FEV1 = 12% and absolute change > 200 mL OR change in FVC = 12%
and absolute change > 200 mL at baseline

5. Partial pressure of arterial oxygen (PaO2) < 55 mm Hg

6. Evidence of active infection

7. Listed for lung transplantation

8. Myocardial infarction, coronary artery bypass, or angioplasty within 6 months

9. Unstable angina pectoris or congestive heart failure requiring hospitalization or
deteriorating within 6 months

10. Uncontrolled arrhythmia or hypertension

11. Known HIV, hepatitis C, cirrhosis, or chronic active hepatitis

12. Active substance and/or alcohol abuse

13. If you are pregnant or breastfeeding

14. Any condition other than IPF that is likely to result in your death within the next
year

15. Any condition that, in the judgment of the PI, might cause participation in the study
to be detrimental to you or that the PI deems makes you a poor candidate



Age minimum: 35 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

IPF

Primary Outcome(s)

Progression-free survival [Time Frame: 1 year]

Secondary ID(s)

R01HL109118

UM HUM00004076

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Brown University

National Heart, Lung, and Blood Institute (NHLBI)