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NCT01088607 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis
A Phase 1 study, sponsored by University of Tennessee.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01088607 is a Phase 1 study that has completed, run by University of Tennessee. The registered enrollment target is 27 participants.
The verdict
NCT01088607, a Phase 1 study, has completed, sponsored by University of Tennessee.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
Primary sclerosing cholangitis (PSC), although uncommon, is a devastating and insidiously progressive liver disease, resulting from advancing inflammation, fibrosis and obliteration of the bile ducts in the liver, leading to cirrhosis and end-stage liver disease. Although prognosis in children may be somewhat better than that of adults, approximately one third of pediatric patients require transplantation by adulthood. Other than transplantation, there is to date no therapy conclusively proven to improve the long-term outcome. Ursodeoxycholic acid (UDCA) improves biochemical markers of liver disease, although in high doses does not clearly improve the long-term outcome in adults, and in a recent study may have actually worsened outcome. Childhood PSC is different from that of adult PSC in many ways, and children may derive more short-term, as well as long-term, benefit than adults. This unique multicenter study will carefully monitor the effects of withdrawal and restarting UDCA on liver injury and inflammation in children with PSC. The preliminary data will help in the design of a more definitive larger study to determine if UDCA has a beneficial role in the treatment of PSC in children. Funding Source - FDA OOPD
Interventions
- DRUG ursodeoxycholic acid (UDCA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2010-10 |
| Est. Completion | 2017-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01088607
The ClinicalTrials.gov registry entry for NCT01088607 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Tennessee, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ursodeoxycholic acid (UDCA) is the first listed.
NCT01088607 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01088607 about?
NCT01088607 is a clinical study titled "Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis". Primary sclerosing cholangitis (PSC), although uncommon, is a devastating and insidiously progressive liver disease, resulting from advancing inflammation, fibrosis and obliteration of the bile ducts in the liver, leading to cirrhosis and end-stage liver disease. Although prognosis in children may b...
What is the current status of trial NCT01088607?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2010-10. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01088607?
The interventions under investigation include: ursodeoxycholic acid (UDCA) (DRUG).
Who is sponsoring clinical trial NCT01088607?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
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