NCT03046901

Brief Summary

The purpose of the study is to investigate the safety and efficacy of oral vancomycin in patients with recurrent Primary Sclerosing Cholangitis (PSC) after liver transplantation. The primary endpoint is looking at the effect of the drug on liver function tests, an important surrogate of PSC disease activity at 12 weeks on treatment. Secondary endpoints include a decrease in liver function tests at 1 year, changes in bilirubin and adverse events. Effective treatment at the onset of PSC recurrence may lead to decreases in disease progression, recurrent liver failure, and repeat liver transplantation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2019

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

January 31, 2017

Last Update Submit

March 27, 2019

Conditions

Primary Sclerosing CholangitisPost- Orthotopic Liver Transplantation

Keywords

VancomycinPrimary Sclerosing cholangitisPost-liver transplantation

Outcome Measures

Primary Outcomes (1)

  • Liver Function Test

    Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)

    12 weeks

Secondary Outcomes (2)

  • Liver Function Test

    1 year

  • Liver Function Test

    1 year

Study Arms (1)

Vancomycin group

EXPERIMENTAL

It is a single arm open label study and will constitute only one group that will be taking vancomycin for recurrent PSC post liver transplantation.

Drug: Vancomycin

Interventions

VancomycinDRUG

Vancomycin belongs to the family of medicines called antibiotics.When taken by mouth, is used to treat Clostridium difficile-associated diarrhea (also called C diff). C diff is a type of bacteria that causes severe diarrhea. Oral Vancomycin is also used to treat enterocolitis caused by a certain bacteria (e.g., Staphylococcus aureus). Subjects enrolled in the study will take 500 mg capsule, 3 times per day for 3-12 weeks.

Also known as: Vancocin
Vancomycin group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • History of prior orthotopic liver transplant or liver and kidney transplant.
  • Recurrent PSC confirmed by clinical labs (AST/ALT greater than 19 or ALKP greater than normal), imaging (MRCP or ERCP), and/or liver biopsy consistent with recurrent PSC.
  • No clinical evidence of liver transplant rejection and stability of post-transplant immune suppression dosing for three months prior to enrollment in the study
  • No changes to therapy for inflammatory bowel disease for at least three months prior to enrollment (for patients with history of IBD)
  • Patients on ursodiol must have been on a stable dose for two weeks prior to enrollment and dose must be stable for the remainder of the clinical trial.
  • All patients with inflammatory bowel disease must have had a colonoscopy within a year prior to enrollment
  • No antibiotics for 2 months before starting vancomycin
  • No probiotics for 1 month prior to starting vancomycin or during study period

You may not qualify if:

  • Allergy to vancomycin
  • Pre-existing advanced malignancies
  • Pregnancy or Lactation
  • Inability to provide consent
  • Findings suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, or congenital biliary disease.
  • Current biliary obstruction
  • Active infection
  • Involvement in any other investigational study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The study will be conducted as a prospective open-label pilot study of up to 20 patients who will receive oral vancomycin for 3-12 months as treatment for recurrent PSC after liver transplantation. There will be no masking or randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 8, 2017

Study Start

December 7, 2016

Primary Completion

February 25, 2019

Study Completion

February 25, 2019

Last Updated

March 29, 2019

Record last verified: 2019-03

Locations

US(1)