- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01695174
A Pilot Study of Xifaxan to Treat Patients With PSC (PSC)
October 12, 2014 updated by: Jayant A. Talwalkar, Mayo Clinic
A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
Diagnosis of PSC established by all of the following criteria:
- Alkaline phosphatase >1.5 times upper limit of normal for at least 6 months duration
- Gamma-glutamyl transferase (GGT) >1.5 times upper limit of normal in pediatric patients
- Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with PSC
- Liver histology in the past (if available for review) with features consistent with or diagnostic of PSC
- Both genders
- Adults: Ages 18-75 years.
- Pediatric: Weight > 40 kg
- Patient's informed consent for study participation
Exclusion criteria:
- Treatment with systematic antibiotics, Azulfidine, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, vitamin E or prednisone in the preceding three months
- Active drug or alcohol use
- Prior history of allergic reaction to the antibiotics which will be used in the study
- Any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully
- Evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites or spontaneous hepatic encephalopathy
- Anticipated need for transplantation in one year (Mayo survival model <80% one-year survival without transplant)
- Findings highly suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis or secondary sclerosing cholangitis
- Treatment with any study medications in the preceding three months
- Pregnancy or current lactation; subjects becoming pregnant during the study despite all the precautions will be withdrawn and referred to their primary physicians
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Xifaxan
Xifaxan 550 mg two times per day for three months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in alkaline phosphatase
Time Frame: Three months
|
An improvement in elevated levels of alkaline phosphatase to less than half of the initial level at study entry
|
Three months
|
Absence of treatment failure
Time Frame: Three months
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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.
|
Three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jayant Talwalkar, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
September 25, 2012
First Submitted That Met QC Criteria
September 25, 2012
First Posted (Estimate)
September 27, 2012
Study Record Updates
Last Update Posted (Estimate)
October 15, 2014
Last Update Submitted That Met QC Criteria
October 12, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-006516
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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