Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004441
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-07
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 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
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
Detailed Description:
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
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
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-FDR001439-01 | None | None | None |
| CHMC-C-001439 | None | None | None |
| CHMC-C-96-1-8 | None | None | None |