229. 肺胞蛋白症（自己免疫性又は先天性） Autoimmune pulmonary alveolar proteinosis Clinical trials / Disease details
臨床試験数 : 43 / 薬物数 : 34 - (DrugBank : 8) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 14
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02702180 (ClinicalTrials.gov) | May 9, 2016 | 28/2/2016 | Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) | A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients IMPALA | Autoimmune Pulmonary Alveolar Proteinosis | Drug: molgramostim;Drug: placebo | Savara Inc. | NULL | Completed | 18 Years | 75 Years | All | 139 | Phase 2/Phase 3 | United States;Australia;Denmark;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Russian Federation;Slovakia;Spain;Switzerland;Turkey;United Kingdom;Poland;Romania |
| 2 | NCT02840708 (ClinicalTrials.gov) | May 2016 | 13/7/2016 | SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study | SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study | Pulmonary Alveolar Proteinosis, Autoimmune | Drug: Sargramostim | Niigata University Medical & Dental Hospital | NULL | Completed | 20 Years | 80 Years | All | 14 | Phase 1 | Japan |
| 3 | NCT02468908 (ClinicalTrials.gov) | May 2015 | 3/6/2015 | Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects | A Randomized, Double-Blind, Placebo-Controlled, Single-Centre, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Molgramostim When Administered by Inhalation to Healthy Adult Subjects | Pulmonary Alveolar Proteinosis;Bronchiectasis;Cystic Fibrosis;Acute Respiratory Distress Syndrome | Drug: Molgramostim;Drug: Placebo | Savara Inc. | Celerion | Completed | 18 Years | 55 Years | All | 42 | Phase 1 | United Kingdom |
| 4 | NCT01983657 (ClinicalTrials.gov) | January 2012 | 7/11/2013 | Study of Subcutaneous Injection of Low-dose rhGM-CSF +/- WLL in PAP. | Study of Subcutaneous Injection of Low-dose Recombinant Granulocyte Macrophage-Colony Stimulating Factor (rhGM-CSF) +/- Whole Lung Lavage(WLL) in Pulmonary Alveolar Proteinosis. | Pulmonary Alveolar Proteinosis | Drug: rhGM-CSF;Procedure: Whole Lung Lavage(WLL) | Shanghai Pulmonary Hospital, Shanghai, China | NULL | Recruiting | 17 Years | 80 Years | Both | 40 | Phase 2 | China |