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Nutritional-GI Completed with Results

DIGEST E: Efficacy and safety of ALTU-135 in patients with CF-related exocrine pancreatic insufficiency (Alnara Altus 726)

This study evaluated the efficacy and safety of liprotamase (a new experimental non-porcine pancreatic enzyme replacement therapy).

The study included a baseline period off enzymes followed by: 1) an open-label treatment period with liprotamase followed by; 2) a treatment period in which participants were randomized to liprotamase or placebo followed by; 3) another open-label treatment period with liprotamase. Pancreatic insufficiency (PI) is found in approximately 90 percent of people with cystic fibrosis (CF) and is treated with enzymes that help enhance digestion, improve growth, reduce gastrointestinal problems and contribute to general nutritional health.

Eligibility

  • Age:

    7 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Study Results

  • What We Learned:

    Study results show that there was a significant improvement in coefficient of fat absorption (or the percentage of fat in the diet that is absorbed by the body) in the treatment group compared with the placebo group. Additionally, there were no serious adverse events associated with liprotamase.

  • Primary Findings:

    Effectiveness:

    This multi-center, multi-national phase 3 study was conducted between May 2007 and June 2008. Of 163 participants who began the initial open-label period #1, 138 were randomized to either liprotamase or placebo for period #2. The primary efficacy endpoint was the difference between the liprotamase and placebo groups for the change in coefficient of fat absorption (CFA) during treatment period #2. Participants treated with liprotamase had a statistically significant improvement in CFA compared to placebo at a fixed dose of one capsule per meal or snack.

     

    Participants treated with liprotamase had a statistically significant improvement in coefficient of nitrogen absorption (CNA, which measures protein absorption) compared to placebo. Stool weight was significantly decreased although not stool frequency.

    Safety:

    Liprotamase was well-tolerated. There were no serious adverse events attributed to the liprotamase treatment.

  • Citation:

    J Cyst Fibros 2011;10(6):443-452

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    10 weeks

  • Number of Study Visits:

    9

Additional Information

  • Phase: ?more info

    Phase Three

  • Study Sponsor: ?more info

    Alnara

  • Study Drugs:

    Liprotamase

Eligibility

  • Age:

    7 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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