Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by University of Tennessee.
NCT01088607 is a Phase 1 study that has completed, run by University of Tennessee. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Phase I-4 weeks, Phase II-4 weeks, Phase III-8 weeks, Phase IV-8 weeks
Interventions
- DRUG ursodeoxycholic acid (UDCA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2010-10 |
| Est. Completion | 2017-06 |
| Phase | Phase 1 |
What the finished NCT01088607 record still lists
NCT01088607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which ursodeoxycholic acid (UDCA) is the first listed.
NCT01088607 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01088607's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00912041 · 27 participants · NA
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
- NCT02847559 · 27 participants · Phase 2
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
- NCT03380195 · 27 participants · NA
Effects of Watermelon Juice on Heart Rate Recovery and Post-exercise Muscle Soreness
- NCT03384238 · 27 participants · Phase 1
Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia