Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anthera Pharmaceuticals

Criteria

Inclusion Criteria:

• Females of childbearing potential must be willing to use birth control

• Diagnosis of CF based upon the following criteria:

• two clinical features consistent with CF; and

• either genotype with two identifiable mutations consistent with CF, OR

• sweat chloride >60 mEq/L by quantitative pilocarpine iontophoresis

• Clinically stable with no evidence of acute upper or lower respiratory tract infection

• PI determined by fecal elastase <100 µg/g stool measured at screening

• Able to take pancreatic enzyme supplementation in the form of capsules

• Able to perform the testing (e.g., stool collections) and inpatient stays required for this study, as judged by the Investigator

• Baseline coefficient of fat absorption (CFA) less than or equal to 80%

Exclusion Criteria:

• CFA >80% at Baseline

• Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control during the study

• History of fibrosing colonopathy

• History of liver transplant, lung transplant or significant surgical resection of the bowel

• Any acute or chronic diarrheal illness unrelated to PI

• Unable to discontinue enteral tube feedings during the study

• Known hypersensitivity to food additives

• Inability to consume the diet required by the study, in the judgment of the Investigator

• Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening

• Abnormal liver function (except for patients with Gilbert Syndrome)

• Signs and/or symptoms of liver cirrhosis, portal hypertension or documented liver disease unrelated to CF

• Distal intestinal obstruction syndrome (DIOS) in the last six months prior to screening

• Unable to discontinue the use of pancreatic enzymes

• Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient

• Patient is unlikely to complete the study, as determined by the Investigator