A Pilot Study of Xifaxan to Treat Patients With PSC

Overview

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.

Full Title of Study: “A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2013

Interventions

  • Drug: Xifaxan

Arms, Groups and Cohorts

  • Experimental: Xifaxan
    • Xifaxan 550 mg two times per day for three months

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Absence of treatment failure
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jayant A. Talwalkar, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Jayant Talwalkar, MD, Principal Investigator, Mayo Clinic

Citations Reporting on Results

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. 2017 Jan/Feb;24(1):e56-e63. doi: 10.1097/MJT.0000000000000102.

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