Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cholestasis |
Drug: tauroursodeoxycholic acid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 1998 |
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.
Eligibility| Ages Eligible for Study: | up to 20 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Minnesota | |
| Children's Hospitals and Clinics - Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Robert Couser 612-813-5913 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | Recruiting |
| Jackson, Mississippi, United States, 39216-4505 | |
| Contact: Phil Rhodes 601-984-5590 | |
| United States, Ohio | |
| Children's Hospital Medical Center - Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Contact: James Heubi 513-636-8046 | |
| Study Chair: | James Heubi | Children's Hospital Medical Center, Cincinnati |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004410 History of Changes |
| Other Study ID Numbers: | 199/13299, CHMC-C-95-9-9, CHMC-C-CRC-473, CHMC-C-FDR001277 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by FDA Office of Orphan Products Development:
|
cholestasis gastrointestinal disorders rare disease |
Additional relevant MeSH terms:
|
Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Tauroursodeoxycholic acid Taurochenodeoxycholic Acid |
Cholagogues and Choleretics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013