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 | NCT03006146 (ClinicalTrials.gov) | July 13, 2017 | 28/11/2016 | Evaluation of a Single Dose of Inhaled Sargramostim in Patients With Autoimmune Pulmonary Alveolar Proteinosis | Evaluation of a Single Dose of Inhaled Sargramostim in Patients With Autoimmune Pulmonary Alveolar Proteinosis | Autoimmune Pulmonary Alveolar Proteinosis | Drug: Sargramostim | Children's Hospital Medical Center, Cincinnati | Rare Diseases Clinical Research Network;National Center for Advancing Translational Science (NCATS) | Completed | 18 Years | 80 Years | All | 10 | Phase 1 | United States |
| 2 | NCT02835742 (ClinicalTrials.gov) | September 1, 2016 | 13/7/2016 | Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan | Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in Japan | Pulmonary Alveolar Proteinosis, Autoimmune | Drug: Sargramostim;Drug: Placebo | Niigata University Medical & Dental Hospital | NULL | Completed | 16 Years | 80 Years | All | 78 | Phase 2 | Japan |
| 3 | 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 |
| 4 | NCT00901511 (ClinicalTrials.gov) | July 2009 | 11/5/2009 | Whole Lung Lavage (WLL)/Inhaled Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis (PAP) | Whole Lung Lavage Followed by Inhaled Sargramostim in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis | Pulmonary Alveolar Proteinosis | Drug: GM-CSF [Leukine (Sargramostim)];Procedure: WLL | IRCCS Policlinico S. Matteo | Agenzia Italiana del Farmaco | Enrolling by invitation | 18 Years | N/A | Both | 18 | Phase 2/Phase 3 | Italy |
| 5 | EUCTR2008-007086-23-IT (EUCTR) | 12/12/2008 | 27/01/2009 | Whole lung lavage followed by inhaled Sargramostim in the treatment of autoimmune pulmonary alveolar proteinosis. - WLL/inhaled GM-CSF in autoimmune PAP | Whole lung lavage followed by inhaled Sargramostim in the treatment of autoimmune pulmonary alveolar proteinosis. - WLL/inhaled GM-CSF in autoimmune PAP | Autoimmune PAP MedDRA version: 9.1;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis | Trade Name: Leukine INN or Proposed INN: Sargramostim | OSPEDALE POLICLINICO S. MATTEO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 6 | NCT00030056 (ClinicalTrials.gov) | September 2001 | 30/1/2002 | GM-CSF in Patients With Pulmonary Alveolar Proteinosis | Trial of GM-CSF for Alveolar Proteinosis | Pulmonary Alveolar Proteinosis | Drug: GM-CSF (granulocyte-macrophage colony-stimulating factor, sargramostim) | The Cleveland Clinic | NULL | Terminated | 18 Years | 70 Years | Both | 48 | Phase 2 | United States |