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 : 44 / 薬物数 : 22 - (DrugBank : 7) / 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 | EUCTR2020-001263-85-ES (EUCTR) | 25/04/2022 | 02/02/2022 | A 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 INN or Proposed INN: Molgramostim | Savara ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 2 | EUCTR2020-001263-85-NL (EUCTR) | 19/07/2021 | 08/10/2020 | A 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 ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Ireland;Turkey;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Netherlands;Germany;Japan;Korea, Republic of | ||
| 3 | NCT04811274 (ClinicalTrials.gov) | June 7, 2021 | 19/3/2021 | Macrophages, GM-CSF and MARS Proteinosis | Study of Macrophage Function and of the GM-CSF Signaling Pathway in Alveolar Proteinosis by Mutations of the MARS Gene | Pulmonary Alveolar Proteinosis (PAP);MARS;Genetic Mutation | Biological: Blood collection;Biological: Bronchoalveolar lavage fluid collection | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | N/A | 17 Years | All | 20 | France | |
| 4 | NCT04544293 (ClinicalTrials.gov) | May 10, 2021 | 3/9/2020 | Clinical 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 Proteinosis | Drug: Molgramostim;Drug: Placebo | Savara Inc. | NULL | Recruiting | 18 Years | N/A | All | 160 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Greece;Ireland;Italy;Japan;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Spain;Turkey;United Kingdom;Russian Federation |
| 5 | EUCTR2020-001263-85-RO (EUCTR) | 11/03/2021 | 19/05/2022 | A 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 ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Spain;Ireland;Turkey;United Kingdom;Italy;France;Canada;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of | ||
| 6 | EUCTR2020-001263-85-BE (EUCTR) | 08/03/2021 | 04/12/2020 | A 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 ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Ireland;Turkey;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of | ||
| 7 | EUCTR2020-001263-85-IE (EUCTR) | 08/02/2021 | 08/10/2020 | A 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 ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Ireland;Turkey;Italy;United Kingdom;France;Canada;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of | ||
| 8 | EUCTR2020-001263-85-DE (EUCTR) | 27/01/2021 | 16/10/2020 | A 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 ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | Portugal;United States;Greece;Spain;Ireland;Turkey;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 9 | EUCTR2020-001263-85-PL (EUCTR) | 16/12/2020 | 19/11/2020 | A 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 ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | Portugal;United States;Greece;Spain;Ireland;Turkey;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 10 | EUCTR2020-001263-85-IT (EUCTR) | 18/11/2020 | 24/05/2021 | A 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 APS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Korea, Democratic People's Republic of;Ireland;Turkey;United Kingdom;Italy;France;Canada;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of | ||
| 11 | NCT03887169 (ClinicalTrials.gov) | September 16, 2019 | 12/3/2019 | Administration 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 Gene | Drug: 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 MRI | Assistance Publique - Hôpitaux de Paris | NULL | Completed | N/A | 18 Years | All | 3 | Phase 1/Phase 2 | France |
| 12 | EUCTR2017-004078-32-IT (EUCTR) | 16/05/2019 | 07/01/2019 | Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation | AN 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 ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Netherlands;France;Greece;Denmark;Russian Federation;Israel;Germany;United Kingdom;Italy | ||
| 13 | EUCTR2017-004078-32-GB (EUCTR) | 05/06/2018 | 01/02/2018 | Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation | AN 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 ApS | NULL | Authorised-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): no | France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 14 | EUCTR2017-004078-32-GR (EUCTR) | 05/06/2018 | 10/05/2018 | Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation | AN 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 15 | EUCTR2017-004078-32-DE (EUCTR) | 30/05/2018 | 18/12/2017 | Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation | AN 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 16 | EUCTR2017-004078-32-NL (EUCTR) | 08/05/2018 | 18/12/2017 | Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation | AN 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | France;Greece;Denmark;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Italy | ||
| 17 | NCT03482752 (ClinicalTrials.gov) | April 16, 2018 | 21/3/2018 | Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis | An Open-label, Non-controlled, Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis Patients | Autoimmune Pulmonary Alveolar Proteinosis | Drug: Molgramostim | Savara Inc. | NULL | Completed | 18 Years | N/A | All | 62 | Phase 3 | Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Russian Federation;Turkey;United Kingdom |
| 18 | EUCTR2017-004078-32-FR (EUCTR) | 22/03/2018 | 18/12/2017 | Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation | AN 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;France;Greece | ||
| 19 | EUCTR2015-003878-33-PT (EUCTR) | 16/02/2018 | 06/11/2017 | A 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Turkey;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of;Greece;Spain;United States;Portugal;Slovakia | ||
| 20 | EUCTR2017-004078-32-DK (EUCTR) | 06/02/2018 | 18/12/2017 | Clinical trial in patients with the lung disease, autoimmune pulmonary alveolar proteinosis, to assess continued treatment with molgramostim by inhalation | AN 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 21 | NCT03231033 (ClinicalTrials.gov) | August 17, 2017 | 19/6/2017 | Pioglitazone Therapy of Autoimmune Pulmonary Alveolar Proteinosis Autoimmune Pulmonary Alveolar Proteinosis | First in Human Study of Pioglitazone Therapy of Autoimmune Pulmonary Alveolar Proteinosis | Autoimmune Pulmonary Alveolar Proteinosis | Drug: Pioglitazone | Children's Hospital Medical Center, Cincinnati | NULL | Completed | 18 Years | 80 Years | All | 3 | Phase 1 | United States |
| 22 | 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 |
| 23 | EUCTR2015-003878-33-ES (EUCTR) | 22/10/2016 | 05/08/2016 | A 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 ApS | NULL | Not 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): no | Portugal;Greece;Spain;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Denmark;Germany;Netherlands;Japan | ||
| 24 | EUCTR2015-003878-33-IT (EUCTR) | 19/09/2016 | 30/08/2016 | A 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 51 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Denmark;Germany;Netherlands;Japan | ||
| 25 | 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 |
| 26 | NCT03316651 (ClinicalTrials.gov) | August 2016 | 27/8/2017 | Sequential Therapy With WLL/Inhaling GM-CSF for Autoimmune Pulmonary Alveolar Proteinosis | A 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 China | Pulmonary Alveolar Proteinosis;Treatment | Drug: GM-CSF | Dai Huaping | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | China |
| 27 | JPRN-JMA-IIA00205 | 20/07/2016 | 07/01/2015 | Pulmonary alveolar proteinosis GM-CSF inhalation efficacy trial in Japan | Pulmonary alveolar proteinosis GM-CSF inhalation efficacy trial in Japan | autoimmune pulmonary alveolar proteinosis | Intervention 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 Nakata | Partner Therapeutics | Completed | >=16 YEARS | <=80 YEARS | BOTH | 80 | Phase 2-3 | Japan |
| 28 | 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 |
| 29 | EUCTR2015-003878-33-GR (EUCTR) | 05/04/2016 | 17/03/2016 | A 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/S | NULL | Not 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): no | Portugal;Greece;Spain;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 30 | NCT02702180 (ClinicalTrials.gov) | March 21, 2016 | 28/2/2016 | Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis | A Randomised, Double-blind, Placebo-controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis Patients | Autoimmune Pulmonary Alveolar Proteinosis | Drug: Molgramostim;Drug: Placebo;Device: PARI eFlow nebulizer system | Savara Inc. | NULL | Completed | 18 Years | N/A | All | 139 | Phase 2 | 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 |
| 31 | EUCTR2015-003878-33-DE (EUCTR) | 22/02/2016 | 11/11/2015 | A 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 ApS | NULL | Not 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): no | Portugal;United States;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 32 | EUCTR2015-003878-33-GB (EUCTR) | 28/01/2016 | 22/10/2015 | A 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 ApS | NULL | Not 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): no | Portugal;United States;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Poland;Romania;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 33 | EUCTR2015-003878-33-NL (EUCTR) | 19/01/2016 | 28/10/2015 | A 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2;Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 34 | EUCTR2015-003878-33-DK (EUCTR) | 11/12/2015 | 23/10/2015 | A 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2;Phase 3 | Slovakia;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of;United States;Portugal | ||
| 35 | 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 |
| 36 | NCT02243228 (ClinicalTrials.gov) | August 2014 | 14/9/2014 | Inhalation 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 Study | Autoimmune Pulmonary Alveolar Proteinosis | Drug: GM-CSF | Peking Union Medical College Hospital | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | 18 Years | N/A | Both | 42 | Phase 2 | China |
| 37 | NCT01842386 (ClinicalTrials.gov) | April 29, 2014 | 25/4/2013 | Rituximab for Anti-cytokine Autoantibody-Associated Diseases | Rituximab (Anti-CD20) for the Treatment of Subjects With Anticytokine Autoantibody-Associated Diseases | Pulmonary Alveolar Proteinosis (PAP);Severe Mucocutaneous Candidiasis | Drug: Rituximab | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | N/A | All | 7 | Phase 1 | United States |
| 38 | NCT01511068 (ClinicalTrials.gov) | August 2012 | 12/12/2011 | Inhaled 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 Proteinosis | Drug: Leukine | Children's Hospital Medical Center, Cincinnati | Virginia Commonwealth University;Genzyme, a Sanofi Company | Completed | 8 Years | N/A | All | 2 | Phase 2 | United States |
| 39 | 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 |
| 40 | 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 |
| 41 | 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 | ||||
| 42 | NCT00552461 (ClinicalTrials.gov) | January 2007 | 31/10/2007 | Prospective Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis | Prospective Open-Label Trial of Rituximab for Primary Pulmonary Alveolar Proteinosis | Pulmonary Alveolar Proteinosis;Primary Disease | Drug: rituximab | East Carolina University | Genentech, Inc. | Recruiting | 18 Years | N/A | Both | 10 | Phase 2 | United States |
| 43 | 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 |
| 44 | JPRN-JMA-IIA00013 | 16/08/2007 | A 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 proteinosis | Intervention 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 Hospital | Toshihiro 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 Hospital | Completed | >=16 YEARS | <=80 YEARS | BOTH | 40 | Phase 2 | Japan |