A Pilot Study of Xifaxan to Treat Patients With PSC

Phase 1

Completed

• Conditions: Primary Sclerosing Cholangitis (PSC)
• Interventions: Drug: Xifaxan

• Registration Number: NCT01695174
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-27
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-12
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Xifaxan	Xifaxan	Xifaxan 550 mg two times per day for three months

Primary Outcome Measures

Name	Time	Method
Improvement in alkaline phosphatase	Three months	An improvement in elevated levels of alkaline phosphatase to less than half of the initial level at study entry
Absence of treatment failure	Three months	Absence of treatment failure which is defined as any of the following: death, need for liver transplantation, side effects requiring discontinuation of therapy, worsening of liver biochemistries, voluntary discontinuation for any reason, marked worsening of fatigue or itching.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States