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

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, August 1998

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Children's Hospital Medical Center, Cincinnati
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004410

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

Drug Information available for: Tauroursodeoxycholic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	50
Study Start Date:	June 1998

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.

Eligibility

Ages Eligible for Study:	up to 20 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004410

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

Sponsors and Collaborators

FDA Office of Orphan Products Development

Children's Hospital Medical Center, Cincinnati

Investigators

Study Chair:

James Heubi

Children's Hospital Medical Center, Cincinnati

More Information

No publications provided

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
ClinicalTrials.gov Identifier:	NCT00004410 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

cholestasis
gastrointestinal disorders
rare disease

Study placed in the following topic categories:

Taurochenodeoxycholic Acid
Digestive System Diseases
Bile Duct Diseases
Cholestasis
Gastrointestinal Diseases

Biliary Tract Diseases
Tauroursodeoxycholic acid
Rare Diseases
Antiviral Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Taurochenodeoxycholic Acid
Digestive System Diseases
Bile Duct Diseases
Cholestasis
Therapeutic Uses

Cholagogues and Choleretics
Biliary Tract Diseases
Tauroursodeoxycholic acid
Gastrointestinal Agents
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009