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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00162760
Eligibility Criteria:
Inclusion Criteria:
* Clinical history consistent with IPF for greater than or equal to 3 months duration and less than 5 years.
* Documented IPF with UIP on histologic examination of surgical lung biopsy confirmed by study physician (RT).
* High resolution CT (HRCT) of chest consistent with IPF (bibasilar reticular abnormalities with minimal ground glass opacities) as determined by study physician (KMH).
* Failure to have \>/= 10% increase in FVC on prior adequate treatment with corticosteroids and/or cytotoxic drugs, or intolerance to these drugs precluding use.
* FVC \>/= 40% and \</= 90% predicted at screening.
* DLCo \>/= 25% predicted at screening
* Oxygen saturation \>/= 88% on room air or \</= 2L oxygen at screening.
* Age 50-80 inclusive
* Ability to understand and sign informed written consent form and comply with study guidelines
Exclusion Criteria:
* Known etiology of ILD (e.g. sarcoid, hypersensitivity pneumonitis, BOOP etc.)
* Clinically significant toxic or environmental exposure to respiratory irritants (e.g. drugs, asbestosis, radiation etc.)
* Diagnosis of collagen vascular disease.
* Obstruction on PFTs, defined as FEV1/FVC \< 0.6.
* Active infection
* End stage coronary artery disease, congestive heart failure or cor pulmonale
* History of significant peripheral vascular disease
* History of peripheral neuropathy
* History of clinically significant obstructive sleep apnea
* History of poorly controlled diabetes
* Pregnant or lactating women
* Abnormal laboratories as defined as: WBC \< 2300/mm3, HCT \< 30% or \>55%, PLT \< 100k/mm3. creatinine \>1.5, AST or ALT \> 3x normal, total bilirubin \> 1.5.
* Current enrollment in another protocol for IPF
* Prednisone use \>15 mg a day in 4 weeks prior to starting trial.
* Cytotoxic drugs (cyclophosphamide, azathioprine, colchicines, cyclosporine, interferon-gamma) 6 weeks prior to screening.
* Patients requiring chronic narcotic analgesic.
* Patients unable to give informed consent.
* Patients unable to comply with the requirements for the trial.
* Patients with known allergy/intolerance to thalidomide;
* Patients with a predicted life expectance less than 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT00162760
Study Brief:
Protocol Section:
NCT00162760