Safety and efficacy study of four weeks oral administration of tolvaptan in liver cirrhotic patients with hyponatremia and ascites

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000569

Enrollment

104

Registered

2012-11-05

Start date

2012-12-17

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Tolvaptan Group: Tolvaptan Brand name: Samsca, Form: tablet, Dosage: 15mg or 30mg or 60mg, Frequency: once a day, Duration

28 days, Per oral Placebo Group: Placebo, Form: tablet, Dosage: 15mg or 30mg or 60mg, Frequency: once a day, Duration

28 days, Per oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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 2.3 5)Platelet count 3 mg/dL 7) Treatment within 2 weeks with vasopressin anlogues 8)Systolic blood pressure 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)

Design outcomes

Primary

Measure	Time frame
the change in the average daily area under the curve (AUC) for the serum sodium concentration from baseline to day 28	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Korea, Republic of

Contacts

Public ContactWon Hyeok Choe

Konkuk University Medical Center

Outcome results