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NCT00004410 · ClinicalTrials.gov registry record · NA
Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT00004410 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 50 participants.
The verdict
NCT00004410, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- DRUG tauroursodeoxycholic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 1998-06 |
| Est. Completion | 2002-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004410
The ClinicalTrials.gov registry entry for NCT00004410 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which tauroursodeoxycholic acid is the first listed.
NCT00004410 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00004410 about?
NCT00004410 is a clinical study titled "Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants". 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...
What is the current status of trial NCT00004410?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 1998-06. Estimated completion is 2002-03.
What interventions are being tested in trial NCT00004410?
The interventions under investigation include: tauroursodeoxycholic acid (DRUG).
Who is sponsoring clinical trial NCT00004410?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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