Open-Label Phase III Long-Term Safety Trial of Liprotamase
NCT00449904 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214
Last updated 2014-10-24
Summary
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).
Conditions
- Cystic Fibrosis
- Exocrine Pancreatic Insufficiency
Interventions
- DRUG
-
Liprotamase
Administered orally
Sponsors & Collaborators
-
Anthera Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 7 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2009-04-30
- Completion
- 2009-04-30
Countries
- United States
Study Locations
More Related Trials
-
Evaluation of Ivacaftor in Patients Using Ataluren for Nonsense Mutations
NCT03256799 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)
NCT00408317 ·Status: COMPLETED ·Phase: PHASE3
-
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
NCT00775528 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Ataluren (PTC124™) in Cystic Fibrosis
NCT00803205 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)
NCT02139306 ·Status: COMPLETED ·Phase: PHASE3
-
PTC Study to Evaluate Ataluren in Combination With Ivacaftor
NCT03256968 ·Status: COMPLETED ·Phase: PHASE4
-
Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis
NCT00706004 ·Status: COMPLETED ·Phase: NA
-
Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
NCT03551691 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)
NCT00513682 ·Status: COMPLETED ·Phase: PHASE3
-
Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis
NCT02456103 ·Status: TERMINATED ·Phase: PHASE3
-
Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
NCT02415959 ·Status: COMPLETED ·Phase: PHASE2
-
Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
NCT01327703 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Ataluren (PTC124) in Cystic Fibrosis
NCT02107859 ·Status: TERMINATED ·Phase: PHASE3
-
Safety Study of Fenretinide in Adult Patients With Cystic Fibrosis
NCT02141958 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
NCT00981214 ·Status: COMPLETED ·Phase: PHASE3
-
Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
NCT00510484 ·Status: COMPLETED ·Phase: PHASE3
-
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
NCT00690820 ·Status: COMPLETED ·Phase: PHASE3
-
A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
NCT02137382 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
NCT01747330 ·Status: COMPLETED ·Phase: PHASE3
-
Extension Study of Ataluren (PTC124) in Cystic Fibrosis
NCT01140451 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Ataluren in Pediatric Participants With Cystic Fibrosis
NCT00458341 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age
NCT01100606 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis
NCT05719311 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis
NCT05225805 ·Status: COMPLETED ·Phase: PHASE1
-
Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study
NCT00446680 ·Status: COMPLETED ·Phase: PHASE3