299. 嚢胞性線維症
［臨床試験数：1,592，薬物数：1,539（DrugBank：255），標的遺伝子数：81，標的パスウェイ数：162］
Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | EUCTR2017-000571-85-GB (EUCTR) | 19/09/2017 | 11/05/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel;United Kingdom | ||
| 2 | EUCTR2017-000571-85-LT (EUCTR) | 15/09/2017 | 20/07/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 3 | EUCTR2017-000571-85-HU (EUCTR) | 15/06/2017 | 13/04/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 4 | EUCTR2017-000571-85-ES (EUCTR) | 01/06/2017 | 21/04/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 5 | EUCTR2016-002851-92-CZ (EUCTR) | 05/10/2016 | 02/08/2016 | NA | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | United States;Hungary;Czech Republic;Canada;Spain;Poland;Israel | ||
| 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 |
| 6 | EUCTR2016-002851-92-HU (EUCTR) | 08/09/2016 | 25/07/2016 | NA | An 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;Hungary;Canada;Spain;Israel | ||
| 7 | EUCTR2015-002739-17-CZ (EUCTR) | 09/03/2016 | 13/10/2015 | Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Czech Republic;Canada;Spain;Israel | ||
| 8 | EUCTR2015-002739-17-HU (EUCTR) | 30/12/2015 | 13/10/2015 | Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czech Republic;Hungary;Canada;Spain;Israel | ||
| 9 | EUCTR2015-002739-17-ES (EUCTR) | 16/12/2015 | 03/11/2015 | Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czech Republic;Hungary;Canada;Spain;Israel | ||
| 10 | EUCTR2009-012842-21-IT (EUCTR) | 10/08/2010 | 23/08/2010 | A 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 | A 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 SPA | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;United Kingdom;Italy | |||
| 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 |
| 11 | NCT00843817 (ClinicalTrials.gov) | April 2009 | 12/2/2009 | RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum | RhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum | Cystic Fibrosis | Drug: Pulmozyme | University Hospital, Tours | NULL | Completed | 18 Years | N/A | All | 15 | Phase 4 | France |
| 12 | EUCTR2007-000171-41-IT (EUCTR) | 31/12/2007 | 07/01/2008 | A 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 | A 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 INC | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 3 | Italy | ||
| 13 | EUCTR2007-000178-21-IT (EUCTR) | 31/12/2007 | 07/01/2008 | An 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 | An 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 INC | NULL | Not Recruiting | Female: yes Male: yes | 200 | Italy | |||
| 14 | EUCTR2007-000178-21-SK (EUCTR) | 16/07/2007 | 10/04/2008 | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovakia;Italy | ||
| 15 | EUCTR2007-000171-41-SK (EUCTR) | 16/07/2007 | 10/04/2008 | A 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 | A 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 3 | Slovakia;Italy | ||
| 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 |
| 16 | EUCTR2005-000313-35-GB (EUCTR) | 13/04/2005 | 17/03/2005 | A Phase I/II Study to Investigate the Efficacy and Safety of AER 002 in Cystic Fibrosis Given at 3 mg, 10 mg, and 30 mg Doses in Single then Multiple Ascending Doses and to Determine Efficacy of the Highest Tolerable Dose in a 4-Week Proof of Concept Study | A Phase I/II Study to Investigate the Efficacy and Safety of AER 002 in Cystic Fibrosis Given at 3 mg, 10 mg, and 30 mg Doses in Single then Multiple Ascending Doses and to Determine Efficacy of the Highest Tolerable Dose in a 4-Week Proof of Concept Study | Cystic Fibrosis MedDRA version: 7.1;Level: LLT;Classification code 10011762 | Product Name: Recombinant truncated SPINT2 protease inhibitor Product Code: AER002 | Aerovance Inc | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 1;Phase 2 | United Kingdom | ||
| 17 | EUCTR2017-000571-85-PL (EUCTR) | 08/05/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Spain;Poland;Lithuania;Israel;United Kingdom | |||
| 18 | EUCTR2007-000178-21-PL (EUCTR) | 04/09/2007 | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovakia;Poland;Italy | |||
| 19 | EUCTR2007-000171-41-PL (EUCTR) | 11/07/2007 | A 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 | A 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 Inc | NULL | NA | Female: yes Male: yes | 176 | Phase 3 | Slovakia;Poland;Italy | |||
| 20 | EUCTR2016-002851-92-PL (EUCTR) | 02/08/2016 | NA | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Czech Republic;Hungary;Canada;Spain;Poland;Israel |