Study of Subcutaneous Injection of Low-dose rhGM-CSF +/- WLL in PAP.

• Status: Unknown status
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Treatments: Molgramostim; Sargramostim

Criteria

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