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A Pilot Study of Xifaxan to Treat Patients With PSC (PSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01695174
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Jayant A. Talwalkar, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE September 25, 2012
First Posted Date  ICMJE September 27, 2012
Last Update Posted Date October 15, 2014
Study Start Date  ICMJE August 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
  • 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 livertransplantation, side effects requiring discontinuation of therapy, worsening of liver biochemistries, voluntary discontinuation for any reason, marked worsening of fatigue or itching.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Xifaxan to Treat Patients With PSC
Official Title  ICMJE A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Sclerosing Cholangitis (PSC)
Intervention  ICMJE Drug: Xifaxan
Study Arms  ICMJE Experimental: Xifaxan
Xifaxan 550 mg two times per day for three months
Intervention: Drug: Xifaxan
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2014)
16
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2012)
20
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01695174
Other Study ID Numbers  ICMJE 11-006516
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jayant A. Talwalkar, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jayant Talwalkar, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP