A Pilot Study of Xifaxan to Treat Patients With PSC

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jayant A. Talwalkar, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01695174
First received: September 25, 2012
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Primary Sclerosing Cholangitis (PSC)
Drug: Xifaxan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Improvement in alkaline phosphatase [ Time Frame: Three months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Absence of treatment failure which is defined as any of the following: death, need for livertransplantation, side effects requiring discontinuation of therapy, worsening of liver biochemistries, voluntary discontinuation for any reason, marked worsening of fatigue or itching.


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xifaxan
Xifaxan 550 mg two times per day for three months
Drug: Xifaxan

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
    • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695174

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jayant Talwalkar, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Jayant A. Talwalkar, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01695174     History of Changes
Other Study ID Numbers: 11-006516
Study First Received: September 25, 2012
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Primary Sclerosing Cholangitis
Xifaxan

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 16, 2014