Safety and efficacy study of four weeks oral administration of tolvaptan in liver cirrhotic patients with hyponatremia and ascites
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0000569
- Lead Sponsor
- Konkuk University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 104
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)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the change in the average daily area under the curve (AUC) for the serum sodium concentration from baseline to day 28
- Secondary Outcome Measures
Name Time Method the change in the average daily area under the curve (AUC) for the serum sodium concentration from baseline to day 4; the time to normalization of the serum sodium concentration;The time to ascites improvement ;The time to worsening of ascites;the time to first paracentesis, number of paracentesis, the volume of ascitic fluid obtained from paracentesis;The change in the dose of concomitant diuretics from baseline at day 28