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

Phase 4

Terminated

• Conditions: Hyponatremia and Extracellular Fluid in Cirrhotic
• Interventions: Drug: Tolvaptan; Drug: Placebo

• Registration Number: NCT01552590
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Study Start: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-10
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Subjects aged ≥ 20 years
2. 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]
3. Subjects who have been diagnosed with an ascites on the abdominal ultrasound.
4. Subjects who have diagnosed with cirrhosis.
5. Subject or their legally acceptable representatives are able to provide informed consent/assent.

Exclusion Criteria

1. 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
2. Subject who requiring urgent intervention to raise serum sodium acutely
3. Subject who are unable to sense or to respond appropriately to thirst
4. Subject with hypovolemic hyponatremia
5. Subject who should take strong CYP3A inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
6. Subject who are anuric as no benefit is expected
7. Subject who has genetic defects such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
8. Subject who has fluid depletion
9. Female subjects who are pregnant or lactating
10. Subject judged by the investigator to be inappropriate for inclusion in the trial for any other reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tolvaptan	Tolvaptan	Tablet, QD, 2 weeks
Placebo	Placebo	Tablet, QD, 2 weeks

Primary Outcome Measures

Name	Time	Method
Serum Na	2 weeks (Baseline, Day 14)

Secondary Outcome Measures

Name	Time	Method
body weight	7 days
Biochemistry	7 days	Total protein, Albumin, ALP, ALT, AST, r-GT, BUN, Creatinine, Glucose, Cl, K, Na, Ca, Total bilirubin, Uric acid), Hematology (WBC count, Hemoglobin, Hematocrit, Platelets, Serum osm, NT pro-BNP
A composite endpoint of ascites worsening	in case
Serum Na normalization rate	14 days
Physical examination	7 days	HEENT, Thorax, Abdomen, Urogenital, Extremities, Neurological, Skin and Mucosae
Adverse event	Daily
Blood coagulation	7 days	PT, INR
BCM (body composition monitoring)	7 days
Vital signs	Daily
ECG	7 days
Urinalysis	7 days	Protein, pH, Glucose, Blood, Bilirubin, Urobilinogen, Random urine Na/K, Urine osm

Trial Locations

Locations (3)

Soonchunhyang Univ. Bucheon Hospital; 🇰🇷 Bucheon, Korea, Republic of

Hallym Univ. Chuncheon Sacred Heart Hospital; 🇰🇷 Bucheon, Korea, Republic of

Wonju Christian Hospital; 🇰🇷 Wonju, Korea, Republic of