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

  
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1EUCTR2020-001263-85-NL
(EUCTR)
19/07/202108/10/2020A clinical trial where patients with the lung disease autoimmunePulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution byinhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP). - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;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 µg nebulizer solution
INN or Proposed INN: Molgramostim
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Ireland;Turkey;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Netherlands;Germany;Japan;Korea, Republic of
2NCT04811274
(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
3NCT04544293
(ClinicalTrials.gov)
May 10, 20213/9/2020Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)A Randomized, Double-blind, Placebo-controlled Clinical Trial of Once-daily Inhaled Molgramostim Nebulizer Solution in Adult Subjects With Autoimmune Pulmonary Alveolar Proteinosis (aPAP)Autoimmune Pulmonary Alveolar ProteinosisDrug: Molgramostim;Drug: PlaceboSavara Inc.NULLRecruiting18 YearsN/AAll160Phase 3United States;Australia;Belgium;Canada;France;Germany;Greece;Ireland;Italy;Japan;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;Turkey;United Kingdom
4EUCTR2020-001263-85-BE
(EUCTR)
08/03/202104/12/2020A clinical trial where patients with the lung disease autoimmunePulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution byinhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP). - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;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 µg nebulizer solution
INN or Proposed INN: Molgramostim
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Ireland;Turkey;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
5EUCTR2020-001263-85-IE
(EUCTR)
08/02/202108/10/2020A clinical trial where patients with the lung disease autoimmunePulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution by inhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP). - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;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 µg nebulizer solution
INN or Proposed INN: Molgramostim
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Ireland;Turkey;Italy;United Kingdom;France;Canada;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
6EUCTR2020-001263-85-DE
(EUCTR)
27/01/202116/10/2020A clinical trial where patients with the lung disease autoimmunePulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution by inhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP). - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;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 µg nebulizer solution
INN or Proposed INN: Molgramostim
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Ireland;Turkey;Italy;United Kingdom;France;Canada;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
7EUCTR2020-001263-85-PL
(EUCTR)
16/12/202019/11/2020A clinical trial where patients with the lung disease autoimmunePulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution by inhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP). - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;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 µg nebulizer solution
INN or Proposed INN: Molgramostim
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Canada;Poland;Belgium;Romania;Germany;Netherlands;Japan;Korea, Republic of;France;Italy;United Kingdom;Turkey;Ireland;United States
8EUCTR2020-001263-85-IT
(EUCTR)
18/11/202024/05/2021A clinical trial where patients with the lung disease autoimmune Pulmonary Alveolar Proteinosis will be given the drug molgramostim nebulizer solution by inhalation.A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP) - IMPALA-2 Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;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 µg nebulizer solution
Product Code: [na]
INN or Proposed INN: 00201600
SAVARA APSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Korea, Democratic People's Republic of;Ireland;Turkey;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
9NCT04326036
(ClinicalTrials.gov)
March 25, 202026/3/2020Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 InfectionUse of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) InfectionPulmonary Alveolar Proteinosis;COPD;Idiopathic Pulmonary Fibrosis;Viral Pneumonia;Coronavirus Infection;Interstitial Lung DiseaseProcedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF);Device: Centricyte 1000;Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution;Drug: Liberase Enzyme (Roche);Drug: Sterile Normal Saline for Intravenous UseBlack Tie Medical, Inc.Robert W. Alexander, MDEnrolling by invitation18 Years90 YearsAll10Early Phase 1United States
10NCT03887169
(ClinicalTrials.gov)
September 16, 201912/3/2019Administration 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 ParisNULLCompletedN/A18 YearsAll3Phase 1/Phase 2France
11EUCTR2017-004078-32-IT
(EUCTR)
16/05/201907/01/2019Clinical 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-EX Autoimmune 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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Netherlands;France;Greece;Denmark;Russian Federation;Israel;Germany;United Kingdom;Italy
12EUCTR2017-004078-32-GR
(EUCTR)
05/06/201810/05/2018Clinical 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-EX Autoimmune 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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 3France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
13EUCTR2017-004078-32-GB
(EUCTR)
05/06/201801/02/2018Clinical 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-EX Autoimmune 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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;Italy;United Kingdom
14EUCTR2017-004078-32-DE
(EUCTR)
30/05/201818/12/2017Clinical 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-EX Autoimmune 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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 3France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
15EUCTR2017-004078-32-NL
(EUCTR)
08/05/201818/12/2017Clinical 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-EX Autoimmune 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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 3France;Greece;Denmark;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Italy
16NCT03482752
(ClinicalTrials.gov)
April 16, 201821/3/2018Safety 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.NULLCompleted18 YearsN/AAll62Phase 3Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Russian Federation;Turkey;United Kingdom
17EUCTR2017-004078-32-FR
(EUCTR)
22/03/201818/12/2017Clinical 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-EX Autoimmune 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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;France;Greece
18EUCTR2015-003878-33-PT
(EUCTR)
16/02/201806/11/2017A 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 - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 21.1;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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Turkey;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of;Greece;Spain;United States;Portugal;Slovakia
19EUCTR2017-004078-32-DK
(EUCTR)
06/02/201818/12/2017Clinical 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-EX Autoimmune 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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 3France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
20NCT03231033
(ClinicalTrials.gov)
August 17, 201719/6/2017Pioglitazone 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, CincinnatiNULLCompleted18 Years80 YearsAll3Phase 1United States
21NCT03006146
(ClinicalTrials.gov)
July 13, 201728/11/2016Evaluation 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)Completed18 Years80 YearsAll10Phase 1United States
22EUCTR2015-003878-33-ES
(EUCTR)
22/10/201605/08/2016A 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 - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 19.0;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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot Recruiting Female: yes
Male: yes
51 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Denmark;Germany;Netherlands;Japan
23EUCTR2015-003878-33-IT
(EUCTR)
19/09/201630/08/2016A 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 - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 19.0;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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
51Phase 2;Phase 3Portugal;Greece;Spain;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Denmark;Germany;Netherlands;Japan
24NCT02835742
(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
25NCT03316651
(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
26JPRN-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
27NCT02702180
(ClinicalTrials.gov)
May 9, 201628/2/2016Efficacy 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.NULLCompleted18 Years75 YearsAll139Phase 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
28NCT02840708
(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
29EUCTR2015-003878-33-GR
(EUCTR)
05/04/201617/03/2016A 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 IMPALA - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 18.1;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
INN or Proposed INN: MOLGRAMOSTIM
Serendex Pharmaceuticals A/SNULLNot Recruiting Female: yes
Male: yes
51 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands;Japan
30EUCTR2015-003878-33-DE
(EUCTR)
22/02/201611/11/2015A 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 - IMPALA Autoimmune 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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot Recruiting Female: yes
Male: yes
135 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
31EUCTR2015-003878-33-GB
(EUCTR)
28/01/201622/10/2015A 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 - IMPALA Autoimmune 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
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot Recruiting Female: yes
Male: yes
135 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Poland;Romania;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
32EUCTR2015-003878-33-NL
(EUCTR)
19/01/201628/10/2015A 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 - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000015560;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 mcg nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 2;Phase 3United States;Portugal;Slovakia;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of
33EUCTR2015-003878-33-DK
(EUCTR)
11/12/201523/10/2015A 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 - IMPALA Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
MedDRA version: 20.0;Level: LLT;Classification code 10037316;Term: Pulmonary alveolar proteinosis;System Organ Class: 100000015560;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Molgramostim 300 mcg nebuliser solution
INN or Proposed INN: MOLGRAMOSTIM
Savara ApSNULLNot RecruitingFemale: yes
Male: yes
90Phase 2;Phase 3Slovakia;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of;United States;Portugal
34NCT02468908
(ClinicalTrials.gov)
May 20153/6/2015Inhaled 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.CelerionCompleted18 Years55 YearsAll42Phase 1United Kingdom
35NCT02243228
(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
36NCT01842386
(ClinicalTrials.gov)
April 29, 201425/4/2013Rituximab for Anti-cytokine Autoantibody-Associated DiseasesRituximab (Anti-CD20) for the Treatment of Subjects With Anticytokine Autoantibody-Associated DiseasesPulmonary Alveolar Proteinosis (PAP);Severe Mucocutaneous CandidiasisDrug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 YearsN/AAll7Phase 1United States
37NCT01511068
(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
38NCT01983657
(ClinicalTrials.gov)
January 20127/11/2013Study 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, ChinaNULLRecruiting17 Years80 YearsBoth40Phase 2China
39NCT00901511
(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
40EUCTR2008-007086-23-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
41NCT00552461
(ClinicalTrials.gov)
January 200731/10/2007Prospective 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
42NCT00030056
(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
43JPRN-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