Ms1819 (DrugBank: MS-1819)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 298 | 遺伝性膵炎 | 2 |
| 299 | 嚢胞性線維症 | 5 |
| 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 | NCT03481803 (ClinicalTrials.gov) | January 27, 2017 | 6/3/2018 | A Phase IIa Study With Escalating Dose of MS1819-SD | A Multicentre Open-label Phase IIa Study With Escalating Dose of MS1819- SD, to Investigate the Efficacy and Safety of a Yarrowia Lipolytica Lipase Preparation for the Compensation of Exocrine Pancreatic Insufficiency Caused by Chronic Pancreatitis and/or Distal Pancreatectomy | Chronic Pancreatitis;Distal Pancreatectomy | Drug: MS1819-SD | AzurRx SAS | NULL | Completed | 18 Years | N/A | All | 11 | Phase 2 | Australia;France;New Zealand |
| 2 | EUCTR2010-018900-10-FR (EUCTR) | 11/05/2010 | 19/03/2010 | Safety and preliminary clinical activity of Yarrowia lipolytica lipase (MS1819) in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis | Safety and preliminary clinical activity of Yarrowia lipolytica lipase (MS1819) in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis | Exocrine pancreatic insufficiency resulting from chronic pancreatitis MedDRA version: 12.1;Level: LLT;Classification code 10033628;Term: Pancreatic insufficiency | Product Name: MS1819 Product Code: MS1819 INN or Proposed INN: Yarrowia lipolytica lipase | Laboratoires Mayoly Spindler | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | France |
| 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 | NCT04375878 (ClinicalTrials.gov) | July 20, 2020 | 30/4/2020 | OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis | OPTION 2: A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | Exocrine Pancreatic Insufficiency (EPI);Cystic Fibrosis (CF) | Drug: MS1819;Drug: Porcine PERT | AzurRx BioPharma, Inc. | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States;Poland |
| 2 | EUCTR2018-003831-31-ES (EUCTR) | 24/01/2020 | 02/12/2019 | MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis. | A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs | Exocrine Pancreatic Insufficiency MedDRA version: 20.0;Level: LLT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | AzurRx | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Hungary;Spain | |||
| 3 | NCT04302662 (ClinicalTrials.gov) | June 27, 2019 | 4/3/2020 | Phase 2 Combination Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs | A Multicenter, Open-label Phase 2 Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs, to Investigate the Efficacy and Safety of This Combination for the Compensation of Severe Exocrine Pancreatic Insufficiency in CF Patients Not Fully Compensated With Only PPEs | Cystic Fibrosis;Cystic Fibrosis Gastrointestinal Disease;Cystic Fibrosis of Pancreas | Drug: MS1819-SD | AzurRx SAS | NULL | Recruiting | 12 Years | N/A | All | 24 | Phase 2 | Hungary |
| 4 | EUCTR2018-003831-31-HU (EUCTR) | 28/03/2019 | 09/10/2018 | MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis. | A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs - MS1819/18/02 | Exocrine Pancreatic Insufficiency MedDRA version: 20.0;Level: LLT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | AzurRx | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Hungary | |||
| 5 | NCT03746483 (ClinicalTrials.gov) | January 10, 2019 | 15/11/2018 | OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819-SD in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | Exocrine Pancreatic Insufficiency (EPI);Cystic Fibrosis (CF) | Drug: MS1819-SD;Drug: Porcine PERT | AzurRx BioPharma, Inc. | NULL | Completed | 18 Years | N/A | All | 32 | Phase 2 | United States;Poland |