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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 51 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Denmark;Germany;Netherlands;Japan | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 |