Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants

Cholestasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004410
• Other study ID #: 199/13299
• Secondary ID: CHMC-C-95-9-9CHM
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: June 1998
• Est. completion date: March 2002

Study information

• Verified date: August 1998
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Days

Eligibility

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Hospitalized infants who are anticipated to require total parenteral nutrition for greater than 2 weeks and have: Major gastrointestinal anomalies (gastroschisis, ruptured omphalocele) OR Resection (necrotizing enterocolitis, volvulus)

• No evidence of biliary tract abnormalities

• No evidence of other forms of cholestatic liver disease

--Patient Characteristics--

• Renal: No life threatening renal disease

• Cardiovascular: No life threatening cardiovascular disease

• Other: No multiple congenital abnormalities

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis

Intervention

Drug:
• tauroursodeoxycholic acid

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center - Cincinnati	Cincinnati	Ohio
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Children's Hospitals and Clinics - Minneapolis	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States,