The Effect of Oral Taurine on Portal Hemodynamics in Patients With Advanced
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HVPG change in mmHg after 28 days with Taurin 6g or placebo
研究概览
简要总结
The investigators want to analyze the effect of Taurin on portal hemodynamics in patients with advanced liver cirrhosis.
详细描述
28 days of 6 grams Taurine versus Placebo (randomization 1:1).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (male and female) aged older than 18 years with advanced liver cirrhosis (Child's Grade B and Child's Grade C), regardless of the disease origin (viral, alcoholic, idiopathic), who are scheduled for hepatic hemodynamic investigation
- •Negative pregnancy test of women with childbearing potential
- •Patient without beta blocker therapy: due to: intolerance of the medication, preexisting contraindication against beta blocker therapy, endoscopic band ligation as prophylaxis
排除标准
- •History of variceal bleeding without endoscopic band ligation
- •History of endoscopically diagnosed large varices with red spots without previous bleeding and without endoscopic band ligation
- •HVPG < 10 mmHg
- •HVPG > 20 mmHg and varices, unless ligated and treated in an eradication program within 6 months
- •Beta Blocker therapy
- •History of hypersensitivity to the trial drugs and contrast agent or to drugs with similar chemical structure
- •Treatment with vasoactive or non-steroidal anti-inflammatory drugs or systematic antibiotics one week before the study
- •Exclusion criteria for hepatic hemodynamic investigation
- •Cardiac, renal or respiratory failure
- •Previous surgical or transjugular intrahepatic portosystemic shunt
- •Breast-feeding or pregnant women
研究组 & 干预措施
6 capsules Taurin per day
After baseline HVPG (Hepatic Venous Pressure Measurement)patients take 6x1g capsules of GMP produced Taurin per day, on day 28, after intake of the 6x1g Taurin capsules, HVPG measurement will be repeated.
干预措施: Taurin 6g per day per oral for 28 days (Drug)
6 capsules Taurin per day
After baseline HVPG (Hepatic Venous Pressure Measurement)patients take 6x1g capsules of GMP produced Taurin per day, on day 28, after intake of the 6x1g Taurin capsules, HVPG measurement will be repeated.
干预措施: HVPG Measurement baseline (Procedure)
6 capsules Taurin per day
After baseline HVPG (Hepatic Venous Pressure Measurement)patients take 6x1g capsules of GMP produced Taurin per day, on day 28, after intake of the 6x1g Taurin capsules, HVPG measurement will be repeated.
干预措施: HVPG Measurement day 28 (Procedure)
6 capsuless placebo per day
After baseline HVPG measurement patients take 6x1g capsules of placebo per day, on day 28, after intake of the 6x1g placebo capsules, HVPG measurement will be repeated.
干预措施: HVPG Measurement baseline (Procedure)
6 capsuless placebo per day
After baseline HVPG measurement patients take 6x1g capsules of placebo per day, on day 28, after intake of the 6x1g placebo capsules, HVPG measurement will be repeated.
干预措施: HVPG Measurement day 28 (Procedure)
6 capsuless placebo per day
After baseline HVPG measurement patients take 6x1g capsules of placebo per day, on day 28, after intake of the 6x1g placebo capsules, HVPG measurement will be repeated.
干预措施: Placebo 6g per day per oral for 28 days (Drug)
结局指标
主要结局
HVPG change in mmHg after 28 days with Taurin 6g or placebo
时间窗: 28 days
To investigate the response to 6g taurine p.o. for 28 days on the hepatic venous pressure gradient
次要结局
未报告次要终点
研究者
Arnulf Ferlitsch, MD
Assoz. Prof. Dr.
Medical University of Vienna