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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT00552461
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of primary PAP (new or chronic) with presence of anti-GM-CSF antibody
* Moderately symptomatic disease with PaO2 \<70 on room air and on less than 6 L/min oxygen
* Able to give written informed consent and comply with the requirements of the study
* Adequate renal and liver function
* Negative serum pregnancy test (for women of child bearing age) and on acceptable birth control during and after study completion
Exclusion Criteria:
* Severe PAP and requires in-patient care and more urgent therapy with bilateral whole lung lavage
* Treatment with any investigational agent within 4 weeks of screening
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* History of HIV, recurrent significant infection or recurrent bacterial infections
* Known active bacterial, viral, fungal, mycobacterial, or other infection
* Ongoing use of high dose steroids (\>10mg/day) or unstable steroid dose
* Significant cardiac or pulmonary disease or blood disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00552461
Study Brief:
Protocol Section:
NCT00552461