NCT01695174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

1.3 years

First QC Date

September 25, 2012

Last Update Submit

October 12, 2014

Conditions

Primary Sclerosing Cholangitis (PSC)

Keywords

Primary Sclerosing CholangitisXifaxan

Outcome Measures

Primary Outcomes (2)

  • Improvement in alkaline phosphatase

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

    Three months

  • 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.

    Three months

Study Arms (1)

Xifaxan

EXPERIMENTAL

Xifaxan 550 mg two times per day for three months

Drug: Xifaxan

Interventions

XifaxanDRUG
Xifaxan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 24914504RESULT

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Jayant Talwalkar, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2012

First Posted

September 27, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

US(1)