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Bile Acid

Modified vs. Unmodified Ursodiol for Liver Disease

Phase 2

Waitlist Available

Research Sponsored by National Center for Research Resources (NCRR)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with cystic fibrosis-associated liver disease

Patients with chronic cholestatic liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will compare polymer-coated and buffered ursodiol to unmodified ursodiol in order to see which is more effective in treating patients with liver disease.

Who is the study for?

This trial is for individuals with chronic cholestatic liver disease or cystic fibrosis-associated liver disease who maintain a normal diet. It's not suitable for those with serious respiratory issues, acute illness, trouble swallowing, or fertile women.Check my eligibility

What is being tested?

The study aims to compare the bioavailability (how well the body absorbs) of two forms of ursodiol: polymer-coated and buffered versus unmodified. It will also look at differences in itchiness, weight gain, and liver function between these treatments.See study design

What are the potential side effects?

Potential side effects may include gastrointestinal discomfort due to the medication's action on bile acids. Specific side effects related to each form of ursodiol will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have liver disease related to cystic fibrosis.

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I have a long-term liver condition that affects bile flow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Research Resources (NCRR)Lead Sponsor

537 Previous Clinical Trials

316,996 Total Patients Enrolled

1 Trials studying Cholestasis

25 Patients Enrolled for Cholestasis

Children's Hospital Medical Center, CincinnatiOTHER

815 Previous Clinical Trials

6,531,576 Total Patients Enrolled

6 Trials studying Cholestasis

260 Patients Enrolled for Cholestasis

William BalistreriStudy ChairChildren's Hospital Medical Center, Cincinnati

Media Library

Ursodiol (Bile Acid) Clinical Trial Eligibility Overview. Trial Name: NCT00004315 — Phase 2

Cholestasis Clinical Trial 2023: Ursodiol Highlights & Side Effects. Trial Name: NCT00004315 — Phase 2

Ursodiol (Bile Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00004315 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom is this study most likely to produce positive results?

"Eligibility requirements for this cholestasis clinical trial state that patients must be between the ages of 4 months and 0 years old. There is space for 20 total participants in the study."

Answered by AI

Are investigators looking for new participants at this moment?

"The listed clinical trial on clinicaltrials.gov is not presently recruiting patients for the study. The last time this information was updated was on 6/23/2005, although there are 523 other trials that are currently recruiting patients right now."

Answered by AI