Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004442
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Study of Bile Acids in Patients With Peroxisomal Disorders
Sponsor:
University of Cincinnati
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2000-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHMC-C-FDR000995 | None | None | None |