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

  
21 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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
2EUCTR2017-000571-85-GB
(EUCTR)
19/09/201711/05/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel;United Kingdom
3EUCTR2017-000571-85-LT
(EUCTR)
15/09/201720/07/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123
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] - Immune System Diseases [C20]
Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
4EUCTR2017-000571-85-HU
(EUCTR)
15/06/201713/04/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
5EUCTR2017-000571-85-ES
(EUCTR)
01/06/201721/04/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
6EUCTR2016-002851-92-CZ
(EUCTR)
05/10/201602/08/2016NAAn Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Liprotamase
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: LIPASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: PROTEASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: AMYLASE
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 4United States;Hungary;Czech Republic;Canada;Spain;Poland;Israel
7EUCTR2016-002851-92-HU
(EUCTR)
08/09/201625/07/2016NAAn Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Liprotamase
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: LIPASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: PROTEASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: AMYLASE
ANTHERA Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3United States;Hungary;Canada;Spain;Israel
8EUCTR2015-002739-17-CZ
(EUCTR)
09/03/201613/10/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Hungary;Czech Republic;Canada;Spain;Israel
9EUCTR2015-002739-17-HU
(EUCTR)
30/12/201513/10/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czech Republic;Hungary;Canada;Spain;Israel
10EUCTR2015-002739-17-ES
(EUCTR)
16/12/201503/11/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czech Republic;Hungary;Canada;Spain;Israel
11EUCTR2009-012842-21-IT
(EUCTR)
10/08/201023/08/2010A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - NDA randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF)
MedDRA version: 9.1;Level: HLGT;Classification code 10015674
MedDRA version: 9.1;Level: LLT;Classification code 10011762
Trade Name: ZENPEP
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Trade Name: CREON 10000 Capsules
INN or Proposed INN: Multienzymes (lipase, protease etc.)
EURAND SPANULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;United Kingdom;Italy
12EUCTR2007-000171-41-IT
(EUCTR)
31/12/200707/01/2008A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - NDA Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - ND Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency.
MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTUS-135
Product Code: ALTUS-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
ALTUS PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
176Phase 3Italy
13EUCTR2007-000178-21-IT
(EUCTR)
31/12/200707/01/2008An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - NDAn Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - ND Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
ALTUS PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
200Italy
14EUCTR2007-000171-41-SK
(EUCTR)
16/07/200710/04/2008A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyA Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: NA
Other descriptive name: Lipase CLEC
INN or Proposed INN: NA
Other descriptive name: Amylase
INN or Proposed INN: NA
Other descriptive name: Protease
Altus Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
176Phase 3Slovakia;Italy
15EUCTR2007-000178-21-SK
(EUCTR)
16/07/200710/04/2008An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyAn Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: NA
Other descriptive name: Lipase CLEC
INN or Proposed INN: NA
Other descriptive name: Amylase
INN or Proposed INN: NA
Other descriptive name: Protease
Altus Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3Slovakia;Italy
16EUCTR2006-005180-25-DE
(EUCTR)
15/12/200631/10/2006A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group designA study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group design Caucasian males aged between 18 and 50 years of age (inclusive) with cystic fibrosis and pancreatic insufficiency able to discontinue their standard pancreatic enzyme therapy during the treatment phase of the study.
MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Code: LU 70274Nordmark Arzneimittel GmbHNULLNot RecruitingFemale: no
Male: yes
20Germany
17EUCTR2017-000571-85-PL
(EUCTR)
08/05/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Hungary;Spain;Poland;Lithuania;Israel;United Kingdom
18EUCTR2016-002851-92-PL
(EUCTR)
02/08/2016NAAn Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Liprotamase
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: LIPASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: PROTEASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: AMYLASE
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Czech Republic;Hungary;Canada;Spain;Poland;Israel
19EUCTR2018-003831-31-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
20EUCTR2007-000171-41-PL
(EUCTR)
11/07/2007A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyA Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: NA
Other descriptive name: Lipase CLEC
INN or Proposed INN: NA
Other descriptive name: Amylase
INN or Proposed INN: NA
Other descriptive name: Protease
Altus Pharmaceuticals IncNULLNAFemale: yes
Male: yes
176Phase 3Slovakia;Poland;Italy
21EUCTR2007-000178-21-PL
(EUCTR)
04/09/2007An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyAn Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: NA
Other descriptive name: Lipase CLEC
INN or Proposed INN: NA
Other descriptive name: Amylase
INN or Proposed INN: NA
Other descriptive name: Protease
Altus Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3Slovakia;Poland;Italy