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Study Name: Efficacy and Safety of ALTU-135 in Patients with CF Related Exocrine Pancreatic Insufficiency (DIGEST E)
Study Type: Interventional
Intervention Category: Nutritional-GI Therapies
Study Sponsor: Alnara
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Liprotamase
Number of Participants Being Recruited: 176
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study evaluated the efficacy and safety of a new experimental oral pancreatic enzyme replacement therapy. 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. This study examined if people with CF taking ALTU-135, an oral enzyme replacement therapy, would achieve statistically significant improvements in the absorption of fat when compared to people not taking the enzyme.
ELIGIBILITY
Age: >= 7 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00449878?term=altus+safety+and+cf&rank=2
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Patients treated with liprotamase had a statistically significant improvement in CFA compared to placebo. In the liprotamase CFA<40 group, there was an improvement in the mean CFA of 20.2 (80% change from baseline). In the placebo CFA<40 group, there was an increase in mean CFA of 5.1 (24% change from baseline). The mean difference between groups for the change in CFA was 15.1 (p=0.001). Of the 138 patients in the ITT analysis, 68 patients were at CF centers within the United States and 70 patients were at sites outside of the United States. A strong country effect was seen that impacted the overall outcome. For U.S. patients in the overall group who received liprotamase, there was an improvement in the mean CFA of 15.7 (48% change from baseline). For U.S. patients on placebo in the overall group, there was a decrease in the mean CFA of -2.1 (1% change from baseline). The mean difference between groups for the change in CFA was 17.5 (p=<0.001). In contrast, the mean difference in the overall group in countries outside of the U.S. was 4.3.

Secondary Efficacy:

Patients treated with liprotamase had a statistically significant improvement in coefficient of nitrogen absorption (CNA, which measures protein absorption) compared to placebo (p =<0.001). The Phase 3 CNA results paralleled the Phase 3 CFA results. There was not a statistically significant improvement in carbohydrate absorption compared to placebo on the starch challenge test. Importantly, there was a significant decrease in stool weight in liprotamase treated patients compared to placebo (p=0.001).

Safety:

Liprotamase was well-tolerated and had a favorable safety profile in the trial. There were no serious adverse events attributed to the liprotamase treatment.

The summary of data provided here is from a company press release (August 2008). These data may be preliminary and have not been peer-reviewed.

Citation:

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