A Pilot Study of Xifaxan to Treat Patients With PSC

Primary Sclerosing Cholangitis (PSC) Clinical Trial

— PSC  

Official title:

A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695174
• Other study ID #: 11-006516
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2012
• Last updated: October 12, 2014
• Start date: August 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis (PSC)

Intervention

Drug:
• Xifaxan

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tabibian JH, Gossard A, El-Youssef M, Eaton JE, Petz J, Jorgensen R, Enders FB, Tabibian A, Lindor KD. Prospective Clinical Trial of Rifaximin Therapy for Patients With Primary Sclerosing Cholangitis. Am J Ther. 2014 Jun 9. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in alkaline phosphatase	An improvement in elevated levels of alkaline phosphatase to less than half of the initial level at study entry	Three months	No
Primary	Absence of treatment failure	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	Yes