NCT00449904

Open-Label Phase III Long-Term Safety Trial of Liprotamase

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Anthera Pharmaceuticals · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Liprotamase	Administered orally

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-03-21
• Last updated: 2014-10-24

Locations

39 sites across 1 country: United States