Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease

National Center for Research Resources (NCRR)

Status and phase: Unknown; Phase 2

Conditions: Gastrointestinal Diseases; Cholestasis; Cystic Fibrosis

Treatments: Drug: ursodiol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004315

199/11827

UCMC-CHMC-915717

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 4+ months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Chronic cholestatic liver disease

Cystic fibrosis-associated liver disease

--Prior/Concurrent Therapy--

Usual and customary diet maintained throughout study, e.g., medium-chain triglyceride oil

--Patient Characteristics--

Pulmonary: No serious respiratory deficiency

No acute illness

No inability to swallow

No fertile women