AMYLASE ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症16

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-000571-85-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
2EUCTR2017-000571-85-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
3EUCTR2017-000571-85-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
4EUCTR2017-000571-85-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
5EUCTR2016-002851-92-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
6EUCTR2016-002851-92-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
7EUCTR2015-002739-17-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
8EUCTR2015-002739-17-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
9EUCTR2015-002739-17-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
10EUCTR2007-000178-21-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
11EUCTR2007-000171-41-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
12EUCTR2007-000171-41-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
13EUCTR2017-000571-85-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
14EUCTR2016-002851-92-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
15EUCTR2015-001219-11-Outside-EU/EEA
(EUCTR)
31/03/2015A study of the efficacy and tolerability of pancrelipase microtablet (MT) capsules for the treatment of cystic fibrosis-dependent exocrine pancreatic insufficiencyA randomized double-blind (withdrawal) phase 3 study to evaluate the efficacy and tolerability of pancrelipase MT capsules compared with placebo in the treatment of subjects with cystic fibrosis-dependent exocrine pancreatic insufficiency Cystic fibrosis
MedDRA version: 17.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: PANCREASE MT
Product Name: PANCREASE MT
INN or Proposed INN: pancrelipase
Other descriptive name: PANCRELIPASE AMYLASE
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.NULLNAFemale: yes
Male: yes
40Phase 3United States;Canada
16EUCTR2007-000178-21-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