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Study of Bile Acids in Patien...

Study of Bile Acids in Patients With Peroxisomal Disorders

Last Updated: 2015-03-25

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

TERMINATED

Clinical Phase

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1999-04-30

Brief Summary

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OBJECTIVES: I. Determine the effectiveness of oral bile acid therapy with cholic acid, chenodeoxycholic acid, and ursodeoxycholic acid in patients with peroxisomal disorders involving impaired primary bile acid synthesis.

II. Determine whether suppression of synthesis of atypical bile acids and enrichment of bile acid pool with this regimen is effective in treating this patient population and improving quality of life.

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Detailed Description

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PROTOCOL OUTLINE: Patients receive oral cholic acid and oral chenodeoxycholic acid on day 1. On day 4, patients receive oral cholic and ursodeoxycholic acids. Patients are assessed at 3 and 6 months for liver function response, neurologic status, and nutritional status.

Patients receive treatment until disease progression or unacceptable toxic effects are observed.

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

Conditions

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Infantile Refsum's Disease Zellweger Syndrome Bifunctional Enzyme Deficiency Adrenoleukodystrophy

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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chenodeoxycholic acid

Intervention Type DRUG

cholic acid

Intervention Type DRUG

ursodiol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Biochemically proven peroxisomal disorder, including:

* Zellweger syndrome
* Pseudo-Zellweger syndrome
* Neonatal adrenoleukodystrophy
* Bifunctional enzyme deficiency
* Infantile Refsum's disease

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers