Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis - a Prospective Double Blind Randomized Controlled Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- alveolar-arterial oxygen gradient in mmHg
研究概览
简要总结
The most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is the hepatopulmonary syndrome (HPS) with a reported prevalence of 20-47% in patients with hepatic impairment and cirrhosis. HPS is by far the most frequent respiratory complication of cirrhosis. It is a progressive disease leading to significantly increased mortality. Up to date, the only therapeutic option is liver transplantation. The study hypothesis is that administration of bosentan in patients with liver cirrhosis suffering from hepatopulmonary syndrome improves gas exchange. 18 patients with liver cirrhosis fulfilling criteria of HPS according to the ERS task force criteria will be included in this block randomized, double-blind, placebo controlled study (12 patients will be treated with bosentan, 6 with placebo). Patients will receive bosentan 62,5mg b.i.d. for 4 weeks and 125 mg b.i.d. for 8 weeks or placebo. The duration of the treatment phase of the study is 12 weeks. The primary endpoint is the alteration of gas exchange after 3 months of therapy. The expected duration of the study is 2 years.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Presence of HPS
- •Age ≥ 18 years
排除标准
- •Intracardiac shunting
- •Pregnancy
- •Known hypersensitivity to bosentan
- •Use of glyburide
- •Use of cyclosporin A
- •Elevation of aminotransferase level of > 3 times the upper limit of normal
- •Use of rifampicin
- •Females of childbearing potential without use of adequate contraception
- •Systolic blood pressure < 85 mmHg
- •Clinical relevant anemia
- •HIV-infection
研究组 & 干预措施
placebo
Patients will receive placebo tablets twice daily for 3 months.
干预措施: Placebo (Drug)
bosentan
pts. will receive bosentan for 3 months
干预措施: bosentan (Drug)
结局指标
主要结局
alveolar-arterial oxygen gradient in mmHg
时间窗: 3 months
次要结局
- presence of HPS(3 months)
- 6 minutes walking distance in m(3 months)
- aminotransferase level (ASAT, ALAT)(3 months)
- WHO functional class(3 months)
- exhanled nitric oxide in parts per billion(3 months)
- quality of life(3 months)
- hepatic venous pressure gradient (HVPG) in mmHg(3 months)
- pulmonary hemodynamics(3 months)
- mean arterial blood pressue in mmHg(3 months)
- partial pressure of arterial oxygen in mmHg(3 months)
研究者
Valentin Fuhrmann
MD, Associate Professor of Medicine
Medical University of Vienna