NCT00004315

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1995

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2002

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Cystic FibrosisGastrointestinal DiseasesCholestasis

Keywords

cardiovascular and respiratory diseasescholestasiscystic fibrosisgastrointestinal disordersgenetic diseases and dysmorphic syndromesrare disease

Interventions

ursodiolDRUG

Eligibility Criteria

Age4 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

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Sponsors & Collaborators

Study Sites (1)

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Cystic FibrosisGastrointestinal DiseasesCholestasisRespiratory Tract DiseasesGenetic Diseases, InbornRare Diseases

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBile Duct DiseasesBiliary Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Officials

  • William Balistreri

    Children's Hospital Medical Center, Cincinnati

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

November 1, 1995

Last Updated

June 24, 2005

Record last verified: 2002-04

Locations

US(1)