NCT01552590终止4 期
Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Serum Na
研究概览
简要总结
This study is to evaluate the efficacy of a 2-week course of tolvaptan in improving serum sodium and the excretion of extracellular fluid in liver cirrhotic patients with ascites and hyponatremia
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥ 20 years
- •Subjects who have been diagnosed with hyponatremia [serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction]
- •Subjects who have been diagnosed with an ascites on the abdominal ultrasound.
- •Subjects who have diagnosed with cirrhosis.
- •Subject or their legally acceptable representatives are able to provide informed consent/assent.
排除标准
- •Subject who has ascites by other causes (Tbc, CHF, malignancy, or renal disease) acute severe hyponatemia : Serum Na level < 120 mmol/L and Doubt of symptom caused by hyponatremia and the case which should raise serum Na level urgently based on the investigator's judgment international normalized ratio (INR) >3.0 serum sodium ≥135 mmol/L serum potassium > 5.5 mmol/L Creatinine ≥ 2.0 mg/dL Hepatorenal syndrome defined as 'New International Ascites Club's diagnostic criteria' systolic arterial pressure of < 80 mmHg recent myocardial infarction (< 6 month) spontaneous bacterial peritonitis gastrointestinal bleed ( ≤7 days from randomization) ongoing hepatic encephalopathy of > grade1 known hepatocellular carcinoma intractable ascites
- •Subject who requiring urgent intervention to raise serum sodium acutely
- •Subject who are unable to sense or to respond appropriately to thirst
- •Subject with hypovolemic hyponatremia
- •Subject who should take strong CYP3A inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
- •Subject who are anuric as no benefit is expected
- •Subject who has genetic defects such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Subject who has fluid depletion
- •Female subjects who are pregnant or lactating
- •Subject judged by the investigator to be inappropriate for inclusion in the trial for any other reason
研究组 & 干预措施
Tolvaptan
Active Comparator
Tablet, QD, 2 weeks
干预措施: Tolvaptan (Drug)
Placebo
Placebo Comparator
Tablet, QD, 2 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Serum Na
时间窗: 2 weeks (Baseline, Day 14)
次要结局
- A composite endpoint of ascites worsening(in case)
- body weight(7 days)
- Biochemistry(7 days)
- Serum Na normalization rate(14 days)
- Physical examination(7 days)
- Adverse event(Daily)
- Blood coagulation(7 days)
- BCM (body composition monitoring)(7 days)
- Vital signs(Daily)
- ECG(7 days)
- Urinalysis(7 days)
研究者
研究点 (3)
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