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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01983657 |
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Date of registration:
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07/11/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Subcutaneous Injection of Low-dose rhGM-CSF +/- WLL in PAP.
PAP |
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Scientific title:
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Study of Subcutaneous Injection of Low-dose Recombinant Granulocyte Macrophage-Colony Stimulating Factor (rhGM-CSF) +/- Whole Lung Lavage(WLL) in Pulmonary Alveolar Proteinosis. |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01983657 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Huiping Li, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shanghai Pulmonary Hospital, Shanghai, China |
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Name:
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Huiping Li, Doctor |
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Address:
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Telephone:
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86-13817389991 |
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Email:
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liw2013@126.com |
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Affiliation:
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Name:
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Huiping Li, Dr |
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Address:
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Telephone:
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86-13817389991 |
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Email:
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liw2013@126.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
17 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Alveolar Proteinosis
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Intervention(s)
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Drug: rhGM-CSF
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Procedure: Whole Lung Lavage(WLL)
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Primary Outcome(s)
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Improvements in double pulmonary diffuse lesions (Chest CT score )
[Time Frame: 6 months]
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Secondary Outcome(s)
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Improvements in arterial blood gas, including alveolar-arterial oxygen difference(A-aDO2), partial pressure of oxygen(PaO2), partial pressure of carbon dioxide in artery(PaCO2), arterial oxygen saturation(SaO2).
[Time Frame: 6 months]
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Clinical symptoms observation: shod of breath, cough (according to each score standard)
[Time Frame: 6 months]
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Improvements in pulmonary function
[Time Frame: 6 months]
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Granulocyte Macrophage Colony Stimulating Factor(GM-CSF) Antibody titer change
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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