Clinical Effect and Molecular Mechanisms of Action of S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in liver biochemistries
研究概览
简要总结
The aim of this study is to investigate clinical effects (liver biochemistries, health-related quality of life, liver stiffness) and underlying mechanisms of hepatoprotection of S-adenosylmethionine in patients with primary sclerosing cholangitis. The study will be performed in a randomized and placebo-controlled fashion.
详细描述
The study is designed as a randomised, double-blind, placebo-controlled trial.
Eighty participants will be randomized in 1:1 ratio to one of two arms of the study: Intervention or Placebo. Participants in Intervention Group will be treated with S-adenosyl-L-methionine 1200 mg/daily in tablets in two divided doses (800mg in the morning and 400mg midday) over the period of 6 months. Patients in Placebo Group will receive a placebo of identical appearance, smell and taste, with the same schedule.
Participants will be monitored in out-patient clinic at baseline, interim visits at weeks: 4, 12, end of treatment at 24 weeks and follow-up visit after 4-6 weeks wash-out period. Treatment adherence, adverse events, serum biochemistry and health related quality of life will be assessed at each visit. Liver fibrosis will be measured with transient elastography at baseline and at the end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •primary sclerosing cholangitis fulfilling EASL criteria;
- •age: 18 - 75 years;
- •treatment with ursodeoxycholic acid (UDCA) in a dose of 13-15mg/kg b.w. for at least 6 months.
排除标准
- •inability to give informed consent;
- •patients with other forms of chronic liver diseases;
- •decompensated liver cirrhosis (Child-Pugh class B-C);
- •patients with PSC who underwent stenting of their biliary tree within 6 months;
- •other diseases or states that can affect quality of life and mood: decompensated diabetes mellitus, renal insufficiency requiring dialyses, malignancy, heart failure ≥ New York Heart Association (NYHA) II, organ transplantation, known HIV infection, rheumatoid arthritis, asthma, psychiatric disorders;
- •treatment with: steroids, statins, rifampicin, antidepressants;
- •pregnant or breastfeeding women;
- •history of hypersensitivity reactions to S-adenosylmethionine;
- •any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study.
结局指标
主要结局
Change in liver biochemistries
时间窗: 6 months
Change in levels of liver enzymes (Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyltransferase, Alkaline Phosphatase)
Change in liver stiffness
时间窗: 6 months
Change in liver stiffness on liver elastography (measured in kPa)
Change in Health-related Quality of Life
时间窗: 6 months
Change in severity of chronic fatigue and other aspects of health-related quality of life assessed by questionnaire SF-36 (36-Item Short Form Survey).
Change in pruritus severity
时间窗: 6 months
Change in pruritus severity on the Visual Analogue Scale (VAS) - 0 (no pruritus) to 10 (worst pruritus).
Change in PSC-related Quality of Life
时间窗: 6 months
Change in severity of chronic fatigue and other aspects of health-related quality of life assessed by questionnaire PBC-40.
Change in Quality of Life
时间窗: 6 months
Change in severity of generalized anxiety disorder assessed by questionnaire GAD-7 (General Anxiety Disorder-7).
次要结局
- Molecular assesment of hepatoprotective properties of SAMe(6 months)