ALTU-135 for the Treatment of CF Exocrine Pancreatic Insufficiency
Number of Participants Being Recruited:
Single / 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.
>= 7 Years
P. aeruginosa status:
B. cepacia status:
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 firstname.lastname@example.org
Subjects maintained and/or gained weight and maintained their BMI z scores and pulmonary function.
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.