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

  
12 trials found
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PhaseCountries
1NCT03481803
(ClinicalTrials.gov)
January 27, 20176/3/2018A Phase IIa Study With Escalating Dose of MS1819-SDA 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 PancreatectomyChronic Pancreatitis;Distal PancreatectomyDrug: MS1819-SDAzurRx SASNULLCompleted18 YearsN/AAll11Phase 2Australia;France;New Zealand
2NCT01430234
(ClinicalTrials.gov)
October 20111/9/2011Enzyme Suppletion in Exocrine Pancreatic DysfunctionEnzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose RegimenChronic Pancreatitis;Exocrine Pancreatic InsufficiencyDrug: Panzytrat 25.000 FIP-E units of LipaseFoundation for Liver ResearchAxcan PharmaCompleted18 Years90 YearsBoth10Phase 4Netherlands
3EUCTR2010-020303-69-NL
(EUCTR)
19/09/201119/09/2011Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPESEnzyme 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 MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Netherlands
4EUCTR2010-018900-10-FR
(EUCTR)
11/05/201019/03/2010Safety and preliminary clinical activity of Yarrowia lipolytica lipase (MS1819) in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitisSafety 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 SpindlerNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12France
5EUCTR2007-000375-42-HU
(EUCTR)
07/04/200814/12/2007A 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 pancreatitisA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
112Hungary;Czech Republic;Denmark;Latvia;Sweden
6EUCTR2008-000061-37-IT
(EUCTR)
02/04/200808/05/2008A 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-002A 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 SPANULLNot RecruitingFemale: yes
Male: yes
72Italy
7NCT00559052
(ClinicalTrials.gov)
March 200814/11/2007An 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 InsufficiencyDrug: VIOKASE 16Axcan PharmaAAIPharma;Mayo Clinical Services;City Hospital Laboratory BirminghamCompleted18 YearsN/ABoth22Phase 2United States;Czech Republic
8EUCTR2007-000375-42-DK
(EUCTR)
21/02/200823/10/2007A 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 pancreatitisA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Czech Republic;Denmark;Latvia;Sweden
9EUCTR2007-000375-42-CZ
(EUCTR)
08/02/200817/12/2007A 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 pancreatitisA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Czech Republic;Denmark;Latvia;Sweden
10EUCTR2007-000375-42-LV
(EUCTR)
05/02/200812/02/2008A 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 pancreatitisA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Czech Republic;Denmark;Latvia;Sweden
11NCT00630279
(ClinicalTrials.gov)
February 200822/2/2008Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic PancreatitisA 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 PancreatitisPancreatic Exocrine Insufficiency Due to Chronic PancreatitisDrug: Placebo;Drug: Recombinant Microbial Lipase SLV339Solvay PharmaceuticalsNULLTerminated18 YearsN/ABoth56Phase 2Czech Republic;Denmark;Hungary;Latvia;Poland;Russian Federation;Sweden
12EUCTR2007-000375-42-SE
(EUCTR)
21/12/200726/10/2007A 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 pancreatitisA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Czech Republic;Denmark;Latvia;Sweden