Study of Subcutaneous Injection of Low-dose rhGM-CSF +/- WLL in PAP. (NCT01983657) | Clinical Trial Compass
UnknownPhase 2
Study of Subcutaneous Injection of Low-dose rhGM-CSF +/- WLL in PAP.
China40 participantsStarted 2012-01
Plain-language summary
The purpose of this study is to establish an efficient and economic treatment scheme by evaluation of the safety and efficacy of subcutaneous injection of low-dose rhGM-CSF, or of similar injection after whole lung lavage , in patients with PAP.
Who can participate
Age range
17 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed PAP patients
* Aged 17-80
* Signed informed consent
Exclusion Criteria:
* Secondary PAP
* Received whole lung lavage therapy within 4 weeks before enrollment
* Received previous GM-CSF therapy within 6 months before enrollment
* WBC≥12,000/ul
* fever≥38℃
* Severe edema, severe liver, kidney, lung and cardiovascular disease.
* Pregnant，planning to get pregnant or nursing
* Inability to express the subjective discomfort
* Serious drug allergy history, E.coli preparation or rhGM-CSF serious allergy history
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvements in double pulmonary diffuse lesions （Chest CT score ）
Timeframe: 6 months
Trial details
NCT IDNCT01983657
SponsorShanghai Pulmonary Hospital, Shanghai, China