Clinical Trial: Open-Label Phase III Long-Term Safety Trial of Liprotamase
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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).
Detailed Summary:
Sponsor: Anthera Pharmaceuticals
Current Primary Outcome: Number of participants with an adverse event [ Time Frame: Baseline up to 12 months ]
Original Primary Outcome:
Current Secondary Outcome:
- Change from baseline up to 12 months in body weight Z-scores [ Time Frame: Baseline, up to 12 months ]
- Change from baseline up to 12 months in height Z-scores (up to 17 years in participants age) [ Time Frame: Baseline, up to 12 months ]
- Change from baseline up to 12 months in Body Mass Index (BMI) Z-scores [ Time Frame: Baseline, up to 12 months ]
Original Secondary Outcome:
Information By: Anthera Pharmaceuticals
Dates:
Date Received: March 19, 2007
Date Started: June 2007
Date Completion:
Last Updated: October 15, 2014
Last Verified: October 2014
