Molgramostim (DrugBank: Molgramostim)
2 diseases| 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） | 18 |
| 299 | 嚢胞性線維症 | 2 |
| 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 | NCT04544293 (ClinicalTrials.gov) | February 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 | Not yet recruiting | 18 Years | N/A | All | 160 | Phase 3 | NULL |
| 2 | 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 | ||
| 3 | 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] | Savara ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;Italy;United Kingdom | |||
| 4 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 5 | 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 | ||
| 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 |
| 6 | 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] | Savara ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | France;Greece;Denmark;Russian Federation;Israel;Germany;Netherlands;Italy;United Kingdom | |||
| 7 | 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 | Active, not recruiting | 18 Years | N/A | All | 60 | Phase 3 | Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Russian Federation;Turkey;United Kingdom |
| 8 | 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 | ||
| 9 | 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 | Portugal;United States;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 10 | 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] | Savara ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | France;Greece;Denmark;Russian Federation;Israel;Netherlands;Germany;Italy;United Kingdom | |||
| 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 |
| 11 | 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] | Savara ApS | NULL | Not Recruiting | Female: yes Male: yes | 51 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Denmark;Germany;Netherlands;Japan | |||
| 12 | NCT02702180 (ClinicalTrials.gov) | May 9, 2016 | 28/2/2016 | Efficacy 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 IMPALA | Autoimmune Pulmonary Alveolar Proteinosis | Drug: molgramostim;Drug: placebo | Savara Inc. | NULL | Completed | 18 Years | 75 Years | All | 139 | Phase 2;Phase 3 | 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 |
| 13 | 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] | Serendex Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 51 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands;Japan | |||
| 14 | 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] | Savara ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | |||
| 15 | 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] | Savara ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | 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 | |||
| 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 |
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 |
| 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 | NCT03597347 (ClinicalTrials.gov) | June 20, 2019 | 12/7/2018 | Trial of Inhaled Molgramostim in CF Subjects With NTM Infection | An Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection | Mycobacterium Infections, Nontuberculous;Cystic Fibrosis (CF) | Drug: Molgramostim nebulizer solution;Device: PARI eFlow nebulizer system | Savara Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 2 | 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 |