Oral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Liver Function Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Exclusion Criteria
- •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
排除标准
- 未提供
研究组 & 干预措施
Vancomycin group
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.
干预措施: Vancomycin (Drug)
结局指标
主要结局
Liver Function Test
时间窗: 12 weeks
Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)
次要结局
- Liver Function Test(1 year)
研究者
Shamita Shah
Principal Investigator
Ochsner Health System