Clinical Trial: Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Exocrin

Brief 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 Summary:

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 Inpatient, Double Blind Treatment Period during which half of patients will be withdrawn from treatment and will receive Placebo.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).

Sponsor: Anthera Pharmaceuticals

Current Primary Outcome: Change from open label baseline to end of 6 day double blind treatment period in Coefficient of Fat Absorption (CFA) [ Time Frame: Open label baseline, end of 6 day double blind treatment period ]

Original Primary Outcome:

Current Secondary Outcome:

  • Change from open label baseline to end of 6 day double blind treatment period in Coefficient of nitrogen absorption (CNA) [ Time Frame: Open label baseline, end of 6 day double blind treatment period ]
  • Change from open label baseline to end of 6 day double blind treatment period in number of stools [ Time Frame: Open label baseline, end of 6 day double blind treatment period ]
  • Change from open label baseline to end of 6 day double blind treatment period in stool weight [ Time Frame: Open label baseline, end of 6 day double blind treatment period ]
  • Change from open label baseline to end of 6 day double blind treatment period in maximum blood glucose [ Time Frame: Open label baseline, end of 6 day double blind treatment period ]


Original Secondary Outcome:

Information By: Anthera Pharmaceuticals

Dates:
Date Received: March 19, 2007
Date Started: May 2007
Date Completion:
Last Updated: October 15, 2014
Last Verified: October 2014