Efficacy and Safety of Tolvaptan for Liver Cirrhotic Patients with Hyponatremia and Ascites: A Multi-center, Randomized, Double-blind, Placebo-controlled 4-weeks Clinical Trial

Konkuk University Medical Center0 个研究点目标入组 104 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1) 20 years of age or older
•2) Patients with cirrhosis as diagnosed by liver biopsy or a combination of clinical, biochemical, radiologic and endoscopic findings.
•3) = Grade 2 ascites who have already been treated with restricted salt diet within 3 month
•4) Hyponatremia (Serum sodium = 120 mEq/L and = 130 mEq/L)
•5) Written informed consent

•1)Hypovolemic hyponatremia (Patients with hypotension or chronic heart failure)
•2)Serum potassium concentration > 5.5 mEq/L
•3)Serum bilirubin > 5.0 mg/dL
•4)Blood coagulation factor < 40% or international normalized ratio (INR) > 2.3
•5)Platelet count < 30,000/mm3
•6)Serum creatinine > 3 mg/dL
•7) Treatment within 2 weeks with vasopressin anlogues
•8)Systolic blood pressure <80 mmHg
•9)History of gastrointestinalesophageal varix bleeding variceal hemorrhage
•10)Spontaneous bacterial peritonitis
•11)Hepatic encephalopathy = grade 3
•12)History of Hepatocellular carcinoma treatment within 3month or viable tumor Viable hepatocellular carcinoma
•13)Liver transplant
•14)Previous treatment with transjugular intrahepatic portosystemic stent shunt (TIPS)
•15)History of significant cardiac diseases such as recent myocardial infarction or ischemic diseases within 1 year of screening
•16)Prolonged QTc interval of > 500 ms based on electrocardiography
•17)Treatment within 2 weeks with substances or drugs that may either induce or significantly inhibit cytochrome P450 3A (ketoconazole, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, etc)
•18)Pregnant or breast feeding
•19)Patients with galactose intolerance or malabsorption (as production of the drug contains lactose)
•20)HbA1Cc = 9 %
•21)Serious medical illness (e.g. heart failure, severe pulmonary disorders, alcohol dependence, malignant tumors, etc)

发起方