Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT00262405
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of idiopathic pulmonary fibrosis
* Taking \< 15 mg prednisone for at least 30 days prior to screening
* Age 35-80, inclusive
* Able to understand a written informed consent and comply with the study protocol
Exclusion Criteria:
* Significant environmental exposure
* Diagnosis of collagen vascular disease
* Evidence of active infection
* Clinically significant cardiac disease Myocardial infarction, coronary artery bypass or angioplasty within 6mo Unstable angina pectoris Congestive heart failure requiring hospitalization within 6 months Uncontrolled arrhythmia
* Poorly controlled or severe diabetes mellitus
* Pregnancy or lactation
* Women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant)
* Current enrollment in another experimental protocol
Physiologic Criteria:
* FEV1/FVC \< 0.60
Laboratory Criteria:
* Total bilirubin \> 1.5 X upper limit normal
* AST or ALT \> 3X upper limit normal
* Alkaline phosphatase \> 3X upper limit normal
* White blood cell count \< 2,500/mm3
* Hematocrit \< 30%
* Platelets \< 100,000/mm3
* Prothrombin time INR \> 1.5
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT00262405
Study Brief:
Protocol Section:
NCT00262405