298. 遺伝性膵炎 Hereditary pancreatitis Clinical trials / Disease details
臨床試験数 : 95 / 薬物数 : 148 - (DrugBank : 51) / 標的遺伝子数 : 53 - 標的パスウェイ数 : 142
| 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 | NCT01430234 (ClinicalTrials.gov) | October 2011 | 1/9/2011 | Enzyme Suppletion in Exocrine Pancreatic Dysfunction | Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen | Chronic Pancreatitis;Exocrine Pancreatic Insufficiency | Drug: Panzytrat 25.000 FIP-E units of Lipase | Foundation for Liver Research | Axcan Pharma | Completed | 18 Years | 90 Years | Both | 10 | Phase 4 | Netherlands |
| 3 | EUCTR2010-020303-69-NL (EUCTR) | 19/09/2011 | 19/09/2011 | Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPES | Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPES | Exocrine pancreatic insufficiency in patients with chronic pancreatitis MedDRA version: 12.1;Level: LLT;Classification code 10041969;Term: Steatorrhoea | Trade Name: Panzytrat Product Name: Panzytrat Product Code: RVG 13760 INN or Proposed INN: pancreatic enzymes Other descriptive name: LIPASE | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Netherlands | |||
| 4 | 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 | |||
| 5 | EUCTR2007-000375-42-HU (EUCTR) | 07/04/2008 | 14/12/2007 | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | Pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis | Product Name: Recombinant microbial lipase Product Code: SLV339 | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 112 | Hungary;Czech Republic;Denmark;Latvia;Sweden | |||
| 6 | EUCTR2008-000061-37-IT (EUCTR) | 02/04/2008 | 08/05/2008 | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of two doses of Zentase? (EUR-1008) in Chronic Pancreatitis (CP) patients with Exocrine Pancreatic Insufficiency (EPI) - PR-002 | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of two doses of Zentase? (EUR-1008) in Chronic Pancreatitis (CP) patients with Exocrine Pancreatic Insufficiency (EPI) - PR-002 | Chronic Pancreatitis (CP) with Exocrine Pancreatic Insufficiency (EPI) MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders | Product Name: ZENTASE INN or Proposed INN: Multienzymes (lipase, protease etc.) | EURAND SPA | NULL | Not Recruiting | Female: yes Male: yes | 72 | Italy | |||
| 7 | NCT00559052 (ClinicalTrials.gov) | March 2008 | 14/11/2007 | An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI) | An Open-Label Cross-over Study to Evaluate the Intraduodenal Delivery of Lipase, Protease and Amylase From Administration of VIOKASE16 in Chronic Pancreatitis Subjects With Exocrine Pancreatic Insufficiency (EPI). | Exocrine Pancreatic Insufficiency | Drug: VIOKASE 16 | Axcan Pharma | AAIPharma;Mayo Clinical Services;City Hospital Laboratory Birmingham | Completed | 18 Years | N/A | Both | 22 | Phase 2 | United States;Czech Republic |
| 8 | EUCTR2007-000375-42-DK (EUCTR) | 21/02/2008 | 23/10/2007 | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | Pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis | Product Name: Recombinant microbial lipase Product Code: SLV339 | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Czech Republic;Denmark;Latvia;Sweden | |||
| 9 | EUCTR2007-000375-42-CZ (EUCTR) | 08/02/2008 | 17/12/2007 | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | Pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis | Product Name: Recombinant microbial lipase Product Code: SLV339 | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Czech Republic;Denmark;Latvia;Sweden | |||
| 10 | EUCTR2007-000375-42-LV (EUCTR) | 05/02/2008 | 12/02/2008 | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | Pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis | Product Name: Recombinant microbial lipase Product Code: SLV339 | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Czech Republic;Denmark;Latvia;Sweden | |||
| 11 | NCT00630279 (ClinicalTrials.gov) | February 2008 | 22/2/2008 | Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis | A Multi-center, Single-blind, Parallel-design, Randomized, Placebo-controlled, Dose-ranging Study to Evaluate Oral Recombinant Microbial Lipase Efficacy in Patients With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis | Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis | Drug: Placebo;Drug: Recombinant Microbial Lipase SLV339 | Solvay Pharmaceuticals | NULL | Terminated | 18 Years | N/A | Both | 56 | Phase 2 | Czech Republic;Denmark;Hungary;Latvia;Poland;Russian Federation;Sweden |
| 12 | EUCTR2007-000375-42-SE (EUCTR) | 21/12/2007 | 26/10/2007 | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis | Pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis | Product Name: Recombinant microbial lipase Product Code: SLV339 | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Czech Republic;Denmark;Latvia;Sweden |