Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
Primary Purpose
Cholestasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tauroursodeoxycholic acid
Sponsored by
About this trial
This is an interventional treatment trial for Cholestasis focused on measuring cholestasis, gastrointestinal disorders, rare disease
Eligibility Criteria
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
Sites / Locations
- Children's Hospitals and Clinics - Minneapolis
- University of Mississippi Medical Center
- Children's Hospital Medical Center - Cincinnati
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004410
First Posted
October 18, 1999
Last Updated
March 24, 2015
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT00004410
Brief Title
Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
Study Type
Interventional
2. Study Status
Record Verification Date
August 1998
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
5. Study Description
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 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis
Keywords
cholestasis, gastrointestinal disorders, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tauroursodeoxycholic acid
10. Eligibility
Sex
All
Maximum Age & Unit of Time
20 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Heubi
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospitals and Clinics - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Children's Hospital Medical Center - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
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