Cystic Fibrosis Clinical Trial
OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol
(ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated
liver disease or chronic cholestatic liver disease.
II. Compare the differences in pruritus, weight gain, and liver function for both
treatments.
PROTOCOL OUTLINE:
Patients are sequentially treated with 2 formulations of ursodeoxycholic acid: unmodified
ursodiol (Actigall) and buffered, enteric-coated ursodiol (Ursocarb). There is a 24-hour
washout between each 4-week course of therapy.
;
Primary Purpose: Treatment
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