Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients With Cirrhotic Ascites
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)
研究概览
简要总结
Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management.
详细描述
This is an open label, 12 week dose escalating pilot study of tolvaptan (initiating at 15 mg a day and increasing to 30 mg a day as tolerated in addition to standard ascites treatment) of 10 cirrhotic subjects meeting all inclusion/exclusion criteria. Subjects are monitored for changes in frequency of paracentesis, quantity of ascites removed, and body weight. Additionally, subjects laboratory values were checked frequently during the first days of dosing to ensure tolerability and slow correction/increase in serum sodium.
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
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cirrhosis of liver confirmed by histology and/or combination of ultrasound or endoscopic examination with laboratory evidence
- •Clinically evident ascites treated by diet and/or diuretics
- •History of 1 or more therapeutic paracentesis in the previous 6 months.
排除标准
- •History of variceal bleeding
- •Current or history of Gastrointestinal bleeding within 10 days of screening
- •Ascites from another cause other than liver cirrhosis (i.e. cardiac origin, peritoneal infection, or peritoneal carcinoma)
- •INR (International normalized ratio) > 3.0, neutrophils <1500 cell/μl, platelets < 40,000/μl
- •serum bilirubin > 3 mg/dl
- •serum sodium < 125 meQ (milliequivalent)/L
- •serum potassium <3.5 meQ/L
研究组 & 干预措施
Tolvaptan
Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
干预措施: Tolvaptan (Drug)
结局指标
主要结局
Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)
时间窗: Week 12
Increase in number of therapeutic paracentesis (removal of \> 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing
Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)
时间窗: 12 weeks of study drug
This outcome will provide the number of subjects with a weight increase of \> 2kg from baseline (worsening ascites)
次要结局
- Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)(12 weeks)
- Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)(12 weeks)
- Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)(12 weeks of study drug)