Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis

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

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Study Completion Date

2001-09-30

Brief Summary

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OBJECTIVES: I. Determine the optimum dose of tauroursodeoxycholic acid (TUDCA) required to achieve maximal bioavailability for patients with cystic fibrosis-associated liver disease.

II. Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects on biliary bile acid composition and metabolism, serum biochemistries, fat absorption, and fat-soluble vitamin status in these patients.

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Detailed Description

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PROTOCOL OUTLINE: Objective I: This part of the study is a dose-response study to determine the optimal dose of tauroursodeoxycholic acid (TUDCA). Twenty-four patients are randomized to receive one of three different doses of TUDCA for 3 months.

Objective II: This part of the study is a double-blind crossover study to compare optimized doses of TUDCA with optimized doses of ursodiol in 15 patients stratified according to age (less than 10 vs 10-20 vs more than 20 years). Patients are randomized to receive either TUDCA or ursodiol orally for an initial 3 month period, followed by a 3 month washout period in which no drug is administered. Patients then receive the alternate drug for 3 months.

Completion date provided represents the completion date of the grant per OOPD records

Conditions

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Cystic Fibrosis

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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tauroursodeoxycholic acid

Intervention Type DRUG

ursodiol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

--Prior/Concurrent Therapy--

* At least 3 months since prior ursodiol
* At least 3 months since treatment with drug with choleretic properties or effects that influence bile acid metabolism

--Patient Characteristics--

* Hepatic: No decompensated cirrhosis No hepatic neoplasm or cholelithiasis
* Pulmonary: No significantly impaired pulmonary function with FEV1 less than 50%
* Other: At least 15 kg body weight No severely compromised clinical or nutritional state

Eligible Sex

ALL

Accepts Healthy Volunteers

No