Trials / Terminated
TerminatedNCT00004442
Study of Bile Acids in Patients With Peroxisomal Disorders
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- University of Cincinnati · Academic / Other
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | chenodeoxycholic acid | |
| DRUG | cholic acid | |
| DRUG | ursodiol |
Timeline
- Completion
- 1999-04-01
- First posted
- 1999-10-19
- Last updated
- 2015-03-25
Source: ClinicalTrials.gov record NCT00004442. Inclusion in this directory is not an endorsement.