299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
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. | 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 | EUCTR2018-003831-31-ES (EUCTR) | 24/01/2020 | 02/12/2019 | MS1819-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 | AzurRx | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Hungary;Poland;Spain | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | NCT02750501 (ClinicalTrials.gov) | July 20, 2016 | 20/4/2016 | Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study | Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding | Cystic Fibrosis | Device: RELiZORB (immobilized lipase) cartridge;Other: Impact Peptide 1.5 | Alcresta Therapeutics, Inc. | Cystic Fibrosis Foundation | Completed | 4 Years | N/A | All | 49 | N/A | United States |
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | |||
| 13 | 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 | ||
| 14 | 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 | |||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | EUCTR2006-005180-25-DE (EUCTR) | 15/12/2006 | 31/10/2006 | A 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 | A 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 70274 | Nordmark Arzneimittel GmbH | NULL | Not Recruiting | Female: no Male: yes | 20 | Germany | |||
| 18 | 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 | |||
| 19 | 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 | |||
| 20 | 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 | |||
| 21 | EUCTR2018-003831-31-PL (EUCTR) | 01/12/2020 | MS1819-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 SAS | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Hungary;Spain;Poland;Turkey | |||
| 22 | 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 |