ALTU-135 ( DrugBank: ALTU-135 )


1 disease
IDDisease name (Link within this page)Number of trials
299Cystic fibrosis8

299. Cystic fibrosis


Clinical trials : 1,696 Drugs : 1,644 - (DrugBank : 272) / Drug target genes : 96 - Drug target pathways : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-000171-41-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
2EUCTR2007-000178-21-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
3EUCTR2007-000178-21-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
4EUCTR2007-000171-41-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
5NCT00449904
(ClinicalTrials.gov)
June 200719/3/2007Open-Label Phase III Long-Term Safety Trial of LiprotamaseAn Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients With Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyCystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: LiprotamaseAnthera PharmaceuticalsNULLCompleted7 YearsN/ABoth214Phase 3United States
6NCT00449878
(ClinicalTrials.gov)
May 200719/3/2007Liprotamase Efficacy Trial 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 InsufficiencyCystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: Liprotamase;Drug: PlaceboAnthera PharmaceuticalsNULLCompleted7 YearsN/ABoth163Phase 3United States
7EUCTR2007-000178-21-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
8EUCTR2007-000171-41-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