NCT00449878

Liprotamase Efficacy Trial 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Anthera Pharmaceuticals · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).

Detailed description

This trial is divided into four distinct periods: 1. Baseline Period during which each patient is taken off pancreatic enzyme medications. 2. An Open-Label Treatment Period during which all patients will receive ALTU-135 (liprotamase). 3. Inpatient, Double Blind Treatment Period during which half of patients will be withdrawn from treatment and will receive Placebo. 4. Second Open-Label Treatment Period during which all patients will resume treatment with ALTU-135 (liprotamase).

Conditions

• Cystic Fibrosis
• Exocrine Pancreatic Insufficiency

Interventions

Type	Name	Description
DRUG	Liprotamase	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-03-21
• Last updated: 2014-10-24

Locations

29 sites across 1 country: United States