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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT03231033
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Age ≥ 18 years and ≤ 80 years
* Able to understand and willing to sign a written informed consent document
* Able and willing to complete administration of study drug at home
* Able and willing to adhere to study visit schedule and study procedures
* Diagnosis of aPAP determined by:
* History of a diagnosis of PAP with or without supporting lung histology or BAL/cytology and
* Abnormal serum GM-CSF autoantibody test (GMAb ELISA Test) and
* Chest CT findings compatible with a diagnosis of aPAP
* Evidence of impaired GM-CSF signaling demonstrated by an abnormal STAT5 phosphorylation index (STAT5-PI) test measured in heparinized whole blood at the time screening
* A-aDO2 ≥ 25 mm Hg
Exclusion Criteria:
* Diagnosis of any other PAP-causing disease
* aPAP complicated by:
* Severe disease at screening/enrollment (A-aD02\<55)
* Clinically significant pulmonary fibrosis
* History of any clinically significant:
* Other lung disease
* Cardiovascular disease
* Disease requiring use of systemic steroids in past year
* History of Diabetes Mellitus
* History of untreated osteoporosis
* History of bladder cancer
* Active / serious lung or systemic infection
* Persistent or unexplained fever \>101oF within 2 months of study
* Treatment with an investigational therapeutic agent for aPAP within 3 months prior to enrollment, which includes inhaled GM-CSF
* Abnormal clinical and/or laboratory parameters at screening
* Women who are pregnant or plan to become pregnant
* Concomitant or recent use of specific medicines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03231033
Study Brief:
Protocol Section:
NCT03231033