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:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00030056
Eligibility Criteria:
Inclusion criteria:
* Diagnosis of primary or idiopathic PAP
* Creatinine no greater than 2 mg/dL
* Bilirubin no greater than 2 mg/dL
* Liver enzymes no greater than 3 times normal
* Women must use an effective method of contraception, be post menopausal, or be surgically sterilized
Exclusion criteria:
* Active respiratory infection
* Active cardiovascular disease (e.g., cardiogenic pulmonary edema)
* Underlying myeloproliferative disorder or leukemia
* Other secondary cause of PAP (e.g., occupational exposure to silica or HIV with PCP)
* At increased risk of side effects from GM-CSF therapy (i.e., rheumatoid arthritis, immune thrombocytopenia, or autoimmune thyroiditis)
* Previous therapy with GM-CSF
* Pregnant or nursing
* Significant renal or liver disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00030056
Study Brief:
Protocol Section:
NCT00030056