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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: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT00004410 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00004410 record still lists
NCT00004410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which tauroursodeoxycholic acid is the first listed.
NCT00004410 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004410's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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