NCT03046901

Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

Oral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant Recipients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ochsner Health System · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Sclerosing Cholangitis
• Post- Orthotopic Liver Transplantation

Interventions

Type	Name	Description
DRUG	Vancomycin	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.

Timeline

• Start date: 2016-12-07
• Primary completion: 2019-02-25
• Completion: 2019-02-25
• First posted: 2017-02-08
• Last updated: 2019-03-29

Locations

1 site across 1 country: United States