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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cystic Fibrosis Gastrointestinal Diseases Cholestasis

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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ursodiol

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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William Balistreri

Role: STUDY_CHAIR

Children's Hospital Medical Center, Cincinnati

Locations

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Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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UCMC-CHMC-915717

Identifier Type: -

Identifier Source: secondary_id

199/11827