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NCT00004441 · ClinicalTrials.gov registry record · NA
Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT00004441: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT00004441 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004441, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
OBJECTIVES: I. Determine the optimum dose of tauroursodeoxycholic acid (TUDCA) required to achieve maximal bioavailability for patients with cystic fibrosis-associated liver disease. II. Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects on biliary bile acid composition and metabolism, serum biochemistries, fat absorption, and fat-soluble vitamin status in these patients.
Interventions
- DRUG tauroursodeoxycholic acid
- DRUG ursodiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 1997-09 |
| Est. Completion | 2001-09 |
| Phase | NA |
What the finished NCT00004441 record still lists
NCT00004441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which tauroursodeoxycholic acid is the first listed.
NCT00004441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004441 about?
NCT00004441 is a clinical study titled "Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis". OBJECTIVES: I. Determine the optimum dose of tauroursodeoxycholic acid (TUDCA) required to achieve maximal bioavailability for patients with cystic fibrosis-associated liver disease. II. Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects on biliary bile acid com...
What is the current status of trial NCT00004441?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 1997-09. Estimated completion is 2001-09.
What interventions are being tested in trial NCT00004441?
The interventions under investigation include: tauroursodeoxycholic acid (DRUG), ursodiol (DRUG).
Who is sponsoring clinical trial NCT00004441?
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 NCT00004441's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 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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