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

Primary Purpose

Primary Sclerosing Cholangitis (PSC)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Xifaxan

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis (PSC) focused on measuring Primary Sclerosing Cholangitis, Xifaxan

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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Pregnancy or current lactation; subjects becoming pregnant during the study despite all the precautions will be withdrawn and referred to their primary physicians

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xifaxan

Arm Description

Xifaxan 550 mg two times per day for three months

Outcomes

Primary Outcome Measures

Improvement in alkaline phosphatase

An improvement in elevated levels of alkaline phosphatase to less than half of the initial level at study entry

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01695174

First Posted

September 25, 2012

Last Updated

October 12, 2014

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01695174

Brief Title

A Pilot Study of Xifaxan to Treat Patients With PSC

Acronym

PSC

Official Title

A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sclerosing Cholangitis (PSC)

Keywords

Primary Sclerosing Cholangitis, Xifaxan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Xifaxan

Arm Type

Experimental

Arm Description

Xifaxan 550 mg two times per day for three months

Intervention Type

Drug

Intervention Name(s)

Xifaxan

Primary Outcome Measure Information:

Title

Improvement in alkaline phosphatase

Description

An improvement in elevated levels of alkaline phosphatase to less than half of the initial level at study entry

Time Frame

Three months

Title

Absence of treatment failure

Description

Time Frame

Three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jayant Talwalkar, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24914504

Citation

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.

Results Reference

result

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A Pilot Study of Xifaxan to Treat Patients With PSC

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