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Clinical Trial Finder
Nutritional-GI Completed with Results
RESULT: Study of liprotamase non-porcine enzymes (Anthera AN-EPI3333)
This study evaluated the effectiveness of liprotamase, a non-pig-derived pancreatic enzyme replacement therapy (PERT), as compared to Pancreaze®, a pig-derived PERT.
Participants were randomized to receive liprotamase (a dose 125% of their pre-study PERT) or Pancreaze® (a dose equal to their pre-study PERT) for 4 weeks. During the first 3 weeks of the treatment period, all participants had their dose (either liprotamase or Pancreaze®) adjusted by their physician to achieve an optimal dose based on individual factors such as nutritional status, food consumption, age, weight, etc. The maximum allowable dose for liprotamase was3,750 U lipase-CLEC/kg per meal for ages 17 years and older, or 2,500 U lipase-CLEC/kg per meal for ages less than 17 years old. The maximum allowable dose for Pancreaze® was 2,500 U lipase-CLEC/kg per meal for all ages. For the last week (week 4), participants received the optimal dose that was determined during the first 3 weeks. Following the four-week treatment period, participants who received Pancreaze® were discontinued from the study. Participants who received liprotamase were admitted to the hospital for a confinement period to collect a stool sample and calculate their coefficient of fat absorption (CFA), or the percentage of absorbed fat in the diet. After their hospital stay, liprotamase participants continued to receive liprotamase for 16 weeks.
Eligibility
See other primary eligibility criteria for more information.
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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.
Other Primary Eligibility Criteria
Previous treatment with liprotamase in a clinical trial
Study Results
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What We Learned:
The study was unable to demonstrate that liprotomase was comparable to Pancreaze® with respect to fat absorption (as measured by coefficient of fat absorption, or CFA).
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Primary Findings:
Effectiveness:
The study was conducted between December 2017 and January 2018. The study enrolled 140 participants.
The primary efficacy objective was to demonstrate that liprotamase was comparable to Pancreaze® with respect to the change in coefficient of fat absorption (CFA) from screening to the end of week 4. The study did not meet its primary objective. Although a proportion of participants who received liprotamase maintained or improved their CFA from baseline, a higher proportion of participants experienced a worsening. The average difference between treatment groups in CFA change from baseline was -14.3% with upper and lower 95% confidence intervals of -18.22 and -10.39.
This study found that coefficient of nitrogen absorption (CNA) between liprotamase and Pancreaze® was comparable.
Safety:
These results have been provided from an Anthera Press Release and have not been peer reviewed.
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Citation:
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
30 weeks -
Number of Study Visits:
17
Additional Information
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Phase: ?more info
Phase Three -
Study Sponsor: ?more info
Anthera -
Study Drugs:
Eligibility
See other primary eligibility criteria for more information.
-
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.
Other Primary Eligibility Criteria
Previous treatment with liprotamase in a clinical trial
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