299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174

  
5 trials found
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PhaseCountries
1EUCTR2018-003831-31-ES
(EUCTR)
24/01/202002/12/2019MS1819-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]
Product Name: MS1819-SD
INN or Proposed INN: Lipase Lip2 from Yarrowia lipolytica
Other descriptive name: LIPASE LIP2
AzurRxNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Hungary;Poland;Spain
2NCT04302662
(ClinicalTrials.gov)
June 27, 20194/3/2020Phase 2 Combination Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEsA 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 PPEsCystic Fibrosis;Cystic Fibrosis Gastrointestinal Disease;Cystic Fibrosis of PancreasDrug: MS1819-SDAzurRx SASNULLCompleted12 YearsN/AAll20Phase 2Hungary;Turkey
3EUCTR2018-003831-31-HU
(EUCTR)
28/03/201909/10/2018MS1819-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]
Product Name: MS1819-SDAzurRxNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Hungary;Poland;Spain
4NCT03746483
(ClinicalTrials.gov)
January 10, 201915/11/2018OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic FibrosisA 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 FibrosisExocrine Pancreatic Insufficiency (EPI);Cystic Fibrosis (CF)Drug: MS1819-SD;Drug: Porcine PERTAzurRx BioPharma, Inc.NULLCompleted18 YearsN/AAll32Phase 2United States;Poland
5EUCTR2018-003831-31-PL
(EUCTR)
01/12/2020MS1819-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 due to Cystic Fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000004856
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MS1819-SD
INN or Proposed INN: Lipase Lip2 from Yarrowia lipolytica
Other descriptive name: LIPASE LIP2
AzurRx SASNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Hungary;Spain;Poland;Turkey