GM-CSF ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
229肺胞蛋白症(自己免疫性又は先天性)11

229. 肺胞蛋白症(自己免疫性又は先天性)


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.TrialIDDate_
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PhaseCountries
1NCT04811274
(ClinicalTrials.gov)
June 7, 202119/3/2021Macrophages, GM-CSF and MARS ProteinosisStudy of Macrophage Function and of the GM-CSF Signaling Pathway in Alveolar Proteinosis by Mutations of the MARS GenePulmonary Alveolar Proteinosis (PAP);MARS;Genetic MutationBiological: Blood collection;Biological: Bronchoalveolar lavage fluid collectionAssistance Publique - Hôpitaux de ParisNULLRecruitingN/A17 YearsAll20France
2NCT02835742
(ClinicalTrials.gov)
September 1, 201613/7/2016Pulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in JapanPulmonary Alveolar Proteinosis GM-CSF Inhalation Efficacy Trial in JapanPulmonary Alveolar Proteinosis, AutoimmuneDrug: Sargramostim;Drug: PlaceboNiigata University Medical & Dental HospitalNULLCompleted16 Years80 YearsAll78Phase 2Japan
3NCT03316651
(ClinicalTrials.gov)
August 201627/8/2017Sequential Therapy With WLL/Inhaling GM-CSF for Autoimmune Pulmonary Alveolar ProteinosisA 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 ChinaPulmonary Alveolar Proteinosis;TreatmentDrug: GM-CSFDai HuapingNULLRecruiting18 YearsN/AAll60Phase 2China
4JPRN-JMA-IIA00205
20/07/201607/01/2015Pulmonary alveolar proteinosis GM-CSF inhalation efficacy trial in JapanPulmonary alveolar proteinosis GM-CSF inhalation efficacy trial in Japan autoimmune pulmonary alveolar proteinosisIntervention type:DRUG. Intervention1:GM-CSF inhalation therapy, Dose form:INJECTION, Route of administration:INHALATIONAL, intended dose regimen:125mcg BID inhalation for 7days and 7days without inhalation, 12 cycles. Control intervention1:placebo controlled, Dose form:INJECTION, Route of administration:INHALATIONAL, Intended dose regimen:placebo BID inhalation for 7days and 7days without inhalation, 12 cycles.Koh NakataPartner TherapeuticsCompleted>=16 YEARS<=80 YEARSBOTH80Phase 2-3Japan
5NCT02840708
(ClinicalTrials.gov)
May 201613/7/2016SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic StudySK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic StudyPulmonary Alveolar Proteinosis, AutoimmuneDrug: SargramostimNiigata University Medical & Dental HospitalNULLCompleted20 Years80 YearsAll14Phase 1Japan
6NCT02243228
(ClinicalTrials.gov)
August 201414/9/2014Inhalation of Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Autoimmune Pulmonary Alveolar Proteinosis (PAP)A Prospective Study of Inhaling Granulocyte-macrophage Colony Stimulating Factor in Adult Patients With Mild-to-moderate Autoimmune Pulmonary Alveolar Proteinosis in China: a Randomized Open-label StudyAutoimmune Pulmonary Alveolar ProteinosisDrug: GM-CSFPeking Union Medical College HospitalThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting18 YearsN/ABoth42Phase 2China
7NCT01511068
(ClinicalTrials.gov)
August 201212/12/2011Inhaled Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Hereditary Pulmonary Alveolar Proteinosis (PAP)Inhaled Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Hereditary Pulmonary Alveolar Proteinosis (PAP)Hereditary Pulmonary Alveolar ProteinosisDrug: LeukineChildren's Hospital Medical Center, CincinnatiVirginia Commonwealth University;Genzyme, a Sanofi CompanyCompleted8 YearsN/AAll2Phase 2United States
8NCT00901511
(ClinicalTrials.gov)
July 200911/5/2009Whole 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 ProteinosisPulmonary Alveolar ProteinosisDrug: GM-CSF [Leukine (Sargramostim)];Procedure: WLLIRCCS Policlinico S. MatteoAgenzia Italiana del FarmacoEnrolling by invitation18 YearsN/ABoth18Phase 2/Phase 3Italy
9EUCTR2008-007086-23-IT
(EUCTR)
12/12/200827/01/2009Whole lung lavage followed by inhaled Sargramostim in the treatment of autoimmune pulmonary alveolar proteinosis. - WLL/inhaled GM-CSF in autoimmune PAPWhole 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. MATTEONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
10NCT00030056
(ClinicalTrials.gov)
September 200130/1/2002GM-CSF in Patients With Pulmonary Alveolar ProteinosisTrial of GM-CSF for Alveolar ProteinosisPulmonary Alveolar ProteinosisDrug: GM-CSF (granulocyte-macrophage colony-stimulating factor, sargramostim)The Cleveland ClinicNULLTerminated18 Years70 YearsBoth48Phase 2United States
11JPRN-JMA-IIA00013
16/08/2007A Phase II Study of Inhaled GM-CSF in Patients With Idiopathic Pulmonary Alveolar Proteinosis (iPAP)A Phase II Study of Inhaled GM-CSF in Patients With Idiopathic Pulmonary Alveolar Proteinosis (iPAP) Idiopathic pulmonary alveolar proteinosisIntervention type:DRUG. Intervention1:Granulocyte-macrophage colony stimulating factor (GM-CSF), Dose form:INJECTION, Route of administration:INHALATIONAL, intended dose regimen:Weeks 1-12: 6 cycles of inhaled GM-CSF 125 mcg twice daily on days 1 through 8 of a 14-day
Weeks 13-24: 6 cycles of inhaled GM-CSF 125 mcg once daily on days 1 through 4 of a 14-day cycle.
Koh Nakata, M.D., Ph.D.Bioscience Medical Research Center (BMRC), Niigata University Medical & Dental HospitalToshihiro NUKIWA, M.D., Ph.D., Department of Respiratory Medicine, Tohoku University Medical SchoolYoshikazu INOUE, M.D., Ph.D., National Hospital Organization Kinki-Chuo Chest Medical CenterToshinori TAKADA M.D., Ph.D., Department of Internal Medicine, Niigata University Medical and Dental HospitalCompleted>=16 YEARS<=80 YEARSBOTH40Phase 2Japan