2024-513351-33-00招募中2 期
Telmisartan for portal hypertension in patients with compensated advanced chronic liver disease: A randomized placebo-controlled, double-blind trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary endpoint is defined as the difference between HVPG at W12 and baseline.
研究概览
简要总结
To evaluate the hepatic venous pressure gradient-lowering effects of telmisartan in patients with compensated advanced chronic liver disease and clinically significant portal hypertension after 12 weeks of treatment in comparison to placebo, as measured by hepatic venous pressure gradient decrease
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients with compensated advanced chronic liver disease
- •Age ≥18 years and <80 years
- •Child-Pugh stage A or Child-Pugh stage B and model for end-stage liver disease (MELD) ≤15 points at screening
- •Clinically significant portal hypertension (i.e., hepatic venous pressure gradient ≥10 mmHg) based on an adequate hepatic venous pressure gradient tracing
- •Willingness to provide written informed consent and participate in the study
排除标准
- •Age <18 years and ≥80 years
- •History of transjugular intrahepatic portosystemic shunt
- •Hepatocellular carcinoma
- •Intake of renin inhibitors, angiotensin converting enzyme inhibitors, angiotensin II type 1 receptor blockers, or neprilysin inhibitors
- •Severe hypotension (defined as systolic blood pressure <100 mmHg) at screening
- •Uncontrolled/severe arterial hypertension
- •Alcohol consumption/illicit drug use that is expected to interfere with study procedures
- •Initiation of hepatitis C virus or hepatitis B virus treatment within the last year
- •Allergy or hypersensitivity to telmisartan or contraindications for telmisartan
- •Pregnancy, breastfeeding, or unwillingness to utilize a highly effective means of contraception for the duration of the study in women with childbearing potential
- •Currently decompensated advanced chronic liver disease or history of hepatic decompensation (clinically evident ascites, variceal bleeding, overt hepatic encephalopathy)
- •Child-Pugh stage C or MELD >15 at screening
- •Total bilirubin ≥3 mg/dL or aspartate transaminase/alanine transaminase >5xULN
- •Absence of clinically significant portal hypertension (i.e., hepatic venous pressure gradient <10 mmHg)
- •Cholestatic liver disease (e.g., primary biliary cholangitis, primary sclerosing cholangitis, secondary sclerosing cholangitis)
- •Vascular liver disease
- •Occlusive portal vein thrombosis
- •History of liver transplantation
结局指标
主要结局
The primary endpoint is defined as the difference between HVPG at W12 and baseline.
The primary endpoint is defined as the difference between HVPG at W12 and baseline.
次要结局
- HVPG response after 12 weeks of treatment is defined as an HVPG decrease ≥10%; i.e., HVPG responders).
- Change in liver stiffness measurement (in kPa) between W12 and baseline
- Change in spleen stiffness measurement (in kPa) between W12 and baseline)
研究者
Division of Gastroenterology and Hepatology
Scientific
Medical University Of Vienna
研究点 (1)
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