Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004410
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-08
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 whether infants treated with tauroursodeoxycholic acid TUDCA have a lower peak direct bilirubin ALT AST glutamyltranspeptidase levels and a reduced duration of cholestasis compared to the nontreatment arm
II Determine the significance of lower birth weight and longer duration of total parenteral nutrition TPN on increasing risk of TPN associated cholestasis and increasing benefit from TUDCA therapy
III Determine whether TUDCA therapy leads to significant reduction in the appearance of biliary tract sludge andor stone formation in these infants
IV Determine whether TUDCA therapy leads to reduced urinary excretion of potentially hepatotoxic bile acids as compared to the untreated arm matched for birth weight and duration of TPN
II Determine the significance of lower birth weight and longer duration of total parenteral nutrition TPN on increasing risk of TPN associated cholestasis and increasing benefit from TUDCA therapy
III Determine whether TUDCA therapy leads to significant reduction in the appearance of biliary tract sludge andor stone formation in these infants
IV Determine whether TUDCA therapy leads to reduced urinary excretion of potentially hepatotoxic bile acids as compared to the untreated arm matched for birth weight and duration of TPN
Detailed Description:
PROTOCOL OUTLINE This is a randomized study Patients are stratified by birth weight
Patients are randomized in pairs by birth weight to receive either a placebo in arm I or tauroursodeoxycholic acid TUDCA in arm II TUDCA is administered by mouth nasogastric tube or gastrostomy tube twice daily After 2 weeks of therapy a bile sample is obtained via a duodenal tube An ultrasound examination of the liver and biliary tract is performed after 2 weeks and every 3 weeks thereafter until discontinuation of therapy or until presence of biliary tract sludge is noted on 2 consecutive examinations
Completion date provided represents the completion date of the grant per OOPD records
Patients are randomized in pairs by birth weight to receive either a placebo in arm I or tauroursodeoxycholic acid TUDCA in arm II TUDCA is administered by mouth nasogastric tube or gastrostomy tube twice daily After 2 weeks of therapy a bile sample is obtained via a duodenal tube An ultrasound examination of the liver and biliary tract is performed after 2 weeks and every 3 weeks thereafter until discontinuation of therapy or until presence of biliary tract sludge is noted on 2 consecutive examinations
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHMC-C-FDR001277 | None | None | None |
| CHMC-C-95-9-9 | None | None | None |
| CHMC-C-CRC-473 | None | None | None |