NCT00630942已完成1 期
Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To evaluate the safety and estimate the efficacy at the maximally tolerated dose, 100 mg BID, in 30 patients with PSC.
研究概览
简要总结
The purpose of the study is to see how safe and effective minocycline is in the treatment of Primary Sclerosing Cholangitis (PSC).
详细描述
The purpose of the study is to determine the safety profile of minocycline in patients with PSC and to compare the effects of minocycline on the baseline values of the following parameters: symptoms of pruritus and fatigue, liver biochemistries, Mayo Risk Score, the development of clinical progression and complications of liver disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •Females of childbearing age must have negative pregnancy test within 48 hours of participation and agreement to practice contraception for the duration of the study.
- •Age 18 years old and < than 75 years old.
- •History of chronic cholestatic disease of at least 6 months duration.
- •Serum alkaline phosphatase level at least 1.5 times the upper limit of normal.
- •Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with PSC.
- •Liver biopsy consistent with the diagnosis of PSC.
- •Patient's informed consent for study participation.
排除标准
- •Treatment with tetracyclines, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, pirfenidone, nicotine, tacrolimus, silymarin, vitamin E or prednisone in the preceding three months.
- •Findings highly suggestive of hepatobiliary disease of other etiology complicating PSC.
- •Anticipated need for liver transplantation in one year determined by the Mayo model with an estimate of <75% one year survival without transplantation.
- •Recurrent variceal bleeding, presence of ascites, or encephalopathy.
- •Active drug or alcohol use.
- •Pregnancy.
- •Breast-feeding.
- •Serum creatinine over 1.5 mg/dl.
- •Prior history of allergic reactions to antibiotics belonging to the tetracycline family.
- •Any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully.
- •Patients with active inflammatory bowel disease (IBD) requiring specific treatment in the preceding three months, except for maintenance therapy with 5-ASA compounds, or those individuals who have been involved in a trial evaluating any experimental drug for the treatment of IBD in the preceding three months.
- •Recurrent ascending cholangitis requiring hospitalization in the past year.
研究组 & 干预措施
Single Arm, active treatment
Experimental
干预措施: Minocycline (Drug)
结局指标
主要结局
To evaluate the safety and estimate the efficacy at the maximally tolerated dose, 100 mg BID, in 30 patients with PSC.
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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