An interventional study of tauroursodeoxycholic acid in Cholestasis, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 3 sites in United States. Open to participants aged Up to 20 Days. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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 and/or 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.
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
220 studies on the registry are indexed under Cholestasis; 37 are open to participants now.
This study's planned enrollment of 50 is close to the median of 55 across 135 interventional studies indexed under Cholestasis.
Browse Cholestasis studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Patient Characteristics--
This study is completed, as verified in Aug 1998. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital Medical Center, Cincinnati