Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites

• Status: Unknown status
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the efficacy and safety for the management of hyponatremia and ascites in patients with liver cirrhosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Konkuk University Medical Center
• Collaborators: Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Chungnam National University; Hallym University Medical Center; Hanyang University; Incheon St.Mary's Hospital; Inha University Hospital; Inje University; Korea University Anam Hospital; Kyungpook National University; Kyungpook National University Hospital; Samsung Medical Center; Seoul St. Mary's Hospital; Severance Hospital; Soonchunhyang University Hospital
• Treatments: Tolvaptan

Criteria

Inclusion Criteria:

1. 20 years of age or older

2. Patients with cirrhosis as diagnosed by liver biopsy or a combination of laboratory (thrombocytopenia), radiologic (cirrhotic feature of liver, splenomegaly, collateral shunt on US, CT, or MRI) and endoscopic findings (gastoesophageal varices or portal hypertensive gastropathy)

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

Exclusion Criteria:

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)