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 229. 肺胞蛋白症(自己免疫性又は先天性) [臨床試験数:20,薬物数:15(DrugBank:7),標的遺伝子数:3,標的パスウェイ数:12] 

Searched query = "Autoimmune pulmonary alveolar proteinosis", "Congenital pulmonary alveolar proteinosis", "Hereditary pulmonary alveolar proteinosis", "Pulmonary alveolar proteinosis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03887169April 20191 April 2019Administration of Methionine in Patients With Pulmonary Alveolar Proteinosis by Mutation of the MARS Gene.Oral or Enteral Administration of Methionine in Patients With Pulmonary Alveolar Proteinosis by Mutation of the MARS Gene.Pulmonary Alveolar Proteinosis;Mutation Ala393Thr of the MARS Gene;mutationSer567Leu of the MARS GeneDrug: Methionine;Drug: Vitamin B12, B9, B6, C supplementation;Diagnostic Test: Methionine/homocysteine Dosage;Diagnostic Test: Thoracic CT scan;Diagnostic Test: Abdominal and liver ultrasound.;Diagnostic Test: Brain MRIAssistance Publique - Hôpitaux de ParisNot recruitingN/A10 YearsAll3Phase 1/Phase 2France
2EUCTR2017-004078-32-NL08/05/201828 February 2019Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalationAN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS - IMPALA-EXAutoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0 Level: LLT Classification code 10037316 Term: Pulmonary alveolar proteinosis System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim Nebuliser solution 300 mcg
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
CAS Number: 99283-10-0
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-
Savara ApSAuthorised Female: yes
Male: yes
90Phase 3France;Greece;Denmark;Russian Federation;Israel;Germany;Netherlands;Italy;United Kingdom
3NCT03482752April 16, 201830 September 2019Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar ProteinosisAn Open-label, Non-controlled, Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis PatientsAutoimmune Pulmonary Alveolar ProteinosisDrug: MolgramostimSavara Inc.Recruiting18 YearsN/AAll60Phase 3Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Russian Federation;Turkey;United Kingdom
4NCT03231033August 17, 201711 February 2019Pioglitazone Therapy of Autoimmune Pulmonary Alveolar Proteinosis Autoimmune Pulmonary Alveolar ProteinosisFirst in Human Study of Pioglitazone Therapy of Autoimmune Pulmonary Alveolar ProteinosisAutoimmune Pulmonary Alveolar ProteinosisDrug: PioglitazoneChildren's Hospital Medical Center, CincinnatiNot recruiting18 Years80 YearsAll3Phase 1United States
5NCT03006146July 13, 201711 February 2019Evaluation of a Single Dose of Inhaled Sargramostim in Patients With Autoimmune Pulmonary Alveolar ProteinosisEvaluation of a Single Dose of Inhaled Sargramostim in Patients With Autoimmune Pulmonary Alveolar ProteinosisAutoimmune Pulmonary Alveolar ProteinosisDrug: SargramostimChildren's Hospital Medical Center, CincinnatiRare Diseases Clinical Research Network;National Center for Advancing Translational Science (NCATS)Recruiting18 Years80 YearsAll10Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02835742September 1, 201625 February 2019Pulmonary 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 HospitalNot recruiting16 Years80 YearsAll78Phase 2Japan
7NCT03316651August 201616 December 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 HuapingRecruiting18 YearsN/AAll60Phase 2China
8JPRN-JMA-IIA0020520/07/20162 April 2019Pulmonary alveolar proteinosis GM-CSF inhalation efficacy trial in JapanPulmonary alveolar proteinosis GM-CSF inhalation efficacy trial in Japanautoimmune 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 TherapeuticsNot Recruiting>=16 YEARS<=80 YEARSBOTH80Phase 2-3Japan
9NCT02840708May 20168 January 2018SK-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 HospitalNot recruiting20 Years80 YearsAll14Phase 1Japan
10NCT02702180February 201630 September 2019Efficacy 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 IMPALAAutoimmune Pulmonary Alveolar ProteinosisDrug: molgramostim;Drug: placeboSavara Inc.Not recruiting18 Years75 YearsAll135Phase 2/Phase 3United States;Australia;Denmark;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Russian Federation;Slovakia;Spain;Switzerland;Turkey;United Kingdom;Poland;Romania
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-003878-33-GB28/01/201612 March 2018A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim by inhalation.A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients - IMPALAAutoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0 Level: LLT Classification code 10037316 Term: Pulmonary alveolar proteinosis System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 mcg nebuliser solution
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
CAS Number: 99283-10-0
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use
Savara ApSAuthorisedFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;United States;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Poland;Romania;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
12NCT02468908May 201516 December 2017Inhaled Molgramostim (rhGM-CSF) in Healthy Adult SubjectsA 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 SubjectsPulmonary Alveolar Proteinosis;Bronchiectasis;Cystic Fibrosis;Acute Respiratory Distress SyndromeDrug: Molgramostim;Drug: PlaceboSavara Inc.CelerionNot recruiting18 Years55 YearsAll42Phase 1United Kingdom
13NCT02243228August 201419 February 2015Inhalation 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
14NCT01842386April 25, 20137 October 2019Rituximab for Anti-cytokine Autoantibody-Associated DiseasesRituximab (Anti-CD20) for the Treatment of Subjects With Anticytokine Autoantibody-Associated DiseasesPulmonary Alveolar Proteinosis (PAP);Severe Mucocutaneous CandidoasisDrug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)Not recruiting18 YearsN/AAll7Phase 1United States
15NCT01511068August 201219 February 2015Inhaled 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 CompanyNot recruiting8 YearsN/ABoth2Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01983657January 201219 February 2015Study 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 ProteinosisDrug: rhGM-CSF;Procedure: Whole Lung Lavage(WLL)Shanghai Pulmonary Hospital, Shanghai, ChinaRecruiting17 Years80 YearsBoth40Phase 2China
17EUCTR2008-007086-23-IT12/12/200819 March 2012Whole 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 PAPAutoimmune PAP
MedDRA version: 9.1 Level: LLT Classification code 10037316 Term: Pulmonary alveolar proteinosis
Trade Name: Leukine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sargramostim
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: .5-
OSPEDALE POLICLINICO S. MATTEOAuthorisedFemale: yes
Male: yes
Italy
18NCT00552461January 200719 February 2015Prospective Trial of Rituximab for Primary Pulmonary Alveolar ProteinosisProspective Open-Label Trial of Rituximab for Primary Pulmonary Alveolar ProteinosisPulmonary Alveolar Proteinosis;Primary DiseaseDrug: rituximabEast Carolina UniversityGenentech, Inc.Recruiting18 YearsN/ABoth10Phase 2United States
19NCT00030056September 20017 April 2015GM-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 ClinicNot recruiting18 Years70 YearsBoth48Phase 2United States
20JPRN-JMA-IIA000132 April 2019A 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 School Yoshikazu INOUE, M.D., Ph.D., National Hospital Organization Kinki-Chuo Chest Medical Center Toshinori TAKADA M.D., Ph.D., Department of Internal Medicine, Niigata University Medical and Dental HospitalNot Recruiting>=16 YEARS<=80 YEARSBOTH40Phase 2Japan

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