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Study Name: ALTU-135 for the Treatment of CF Exocrine Pancreatic Insufficiency
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: 200
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study will evaluate the long-term safety of a new oral pancreatic enzyme replacement therapy. 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. Researchers will evaluate people with CF taking ALTU-135,an oral enzyme replacement therapy, for safety concerns during a period of up to one-year.
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: Kirby-Campbell, Ella
(617) 349-3690 X328
ecampbell@alnara.com
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:

Not applicable

Secondary Efficacy:

Subjects maintained and/or gained weight and maintained their BMI z scores and pulmonary function.

Safety:

Two-hundred fifteen subjects 7 years of age and older with CF and exocrine pancreatic insufficiency (EPI) were enrolled in this Phase 3 open-label trial to assess long-term safety, tolerability, and nutritional effects of lipromatase treatment. Subjects initially received 1 capsule orally per meal or snack and the dose could be increased based on protocol-defined parameters (mean 5.5 capsules per day). The treatment period was 12 months.
Liprotamase was well tolerated without any significant safety concerns. Adverse events were primarily gastrointestinal.

Citation:

Not Available
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