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Nutritional-GI Completed with Results

DIGEST S: ALTU-135 for the treatment of CF-related exocrine pancreatic insufficiency (Alnara Altus 767)

This phase 3, open-label study evaluated the long-term safety of liprotamase (a new type of oral pancreatic enzyme replacement therapy). All participants received liprotamase for up to one-year.

Pancreatic insufficiency (PI) is found in approximately 90 percent of people with cystic fibrosis (CF) and is treated through 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:

  • Primary Findings:

    Effectiveness:

    This multi-center, multi-national study was conducted between June 2007 and April 2009. Of the 214 participants, 161 completed 6 months of the study and 145 completed all 12 months. During the first 2 months of treatment dosage adjustments were allowed (most withdrawals occurred during this first 2 months).

     

    After the initial 2 month transition period, height, weight, and BMI z scores were relatively stable over the remaining treatment period.

    Safety:

    Liprotamase was generally well-tolerated. The most commonly reported adverse events were GI related; and there was a marked reduction in these events after the initial transition period coinciding with the dose adjustment by some participants.

  • Citation:

    J Pediatr Gastroenterol Nutr 2012;54(2):248-257

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

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    12 months

  • 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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