Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites (ECF)

Otsuka

Status and phase

Terminated

Phase 4

Conditions

Hyponatremia and Extracellular Fluid in Cirrhotic

Treatments

Drug: Tolvaptan

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01552590

156-KOB-1101i

Details and patient eligibility

About

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

Enrollment

74 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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