A Pilot Study of Xifaxan to Treat Patients With PSC

NCT ID: NCT01695174

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-03-31

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.

Conditions

Primary Sclerosing Cholangitis (PSC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Xifaxan

Xifaxan 550 mg two times per day for three months

Group Type: EXPERIMENTAL

Xifaxan

Intervention Type: DRUG

Interventions

Xifaxan

Intervention Type: DRUG

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jayant A. Talwalkar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jayant Talwalkar, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24914504 (View on PubMed)

Other Identifiers

11-006516

Identifier Type: -

Identifier Source: org_study_id