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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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16 December 2017 |
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Main ID: |
NCT03316651 |
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Date of registration:
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27/08/2017 |
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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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Sequential Therapy With WLL/Inhaling GM-CSF for Autoimmune Pulmonary Alveolar Proteinosis
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Scientific title:
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A Multicenter Clinical Study of the Sequential Therapy With Whole Lung Lavage/Inhaling Granulocyte-macrophage Colony Stimulating Factor in Adult Patients With Severe Autoimmune Pulmonary Alveolar Proteinosis in China |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03316651 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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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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Huaping Dai |
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Address:
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Telephone:
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0086-13901293597 |
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Email:
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daihuaping@sina.com |
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Affiliation:
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Name:
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Huaping Dai |
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Address:
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Telephone:
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0086-13901293597 |
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Email:
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daihuaping@sina.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Comfirmed diagnosis of autoimmune pulmonary alveolar proteinosis
- Disease severity score (DSS) is 4-5
Exclusion Criteria:
- The acute respiratory infection
- Heart failure (such as cardiogenic pulmonary edema)
- The serious liver and kidney dysfunction (creatinine or ALT were equal to or more than
2 times of the upper limit of normal range);
- Pregnancy;
- The patients with hereditary and secondary factors (inhalation of dust, hematological
diseases, autoimmune diseases, etc.);
- DSS is 1-3;
- The patient is allergic to the drugs that be used in our research;
- The patients with poor compliance, or suffering from mental illness;
- The patients have not signed informed consent;
- They were treated with whole lung lavage or regular GM-CSF therapy (treatment for more
than 2 weeks) within 3 months before the enrollment.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Alveolar Proteinosis
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Treatment
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Intervention(s)
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Drug: GM-CSF
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Primary Outcome(s)
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Time to the first relapse (the date: day/month/year)
[Time Frame: Up to 2 years]
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Secondary Outcome(s)
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FEV1 difference
[Time Frame: Up to 2 years]
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Relapse rate
[Time Frame: Up to 2 years]
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Secondary ID(s)
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ChinaJapanFH001
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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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