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NCT01695174 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of Xifaxan to Treat Patients With PSC
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01695174: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT01695174 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01695174, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
In the current protocol, we propose the assessment of potential beneficial effects of the antibiotic Xifaxan on liver biochemistries, liver related symptoms and Mayo risk score in 15 adult and 5 pediatric patients with PSC. Adult patients will receive Xifaxan, 550 mg twice daily over a 12-week period. Pediatric patients with PSC whose weight is greater than or equal to 40 kg will receive Xifaxan, 550 mg twice daily.
Primary Outcome
An improvement in elevated levels of alkaline phosphatase to less than half of the initial level at study entry
Interventions
- DRUG Xifaxan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT01695174 record still lists
NCT01695174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Xifaxan is the first listed.
NCT01695174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01695174 about?
NCT01695174 is a clinical study titled "A Pilot Study of Xifaxan to Treat Patients With PSC". In the current protocol, we propose the assessment of potential beneficial effects of the antibiotic Xifaxan on liver biochemistries, liver related symptoms and Mayo risk score in 15 adult and 5 pediatric patients with PSC. Adult patients will receive Xifaxan, 550 mg twice daily over a 12-week perio...
What is the current status of trial NCT01695174?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-08. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01695174?
The interventions under investigation include: Xifaxan (DRUG).
Who is sponsoring clinical trial NCT01695174?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01695174's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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
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