Single-center, randomized, double-blind, placebo-controlled clinical trial for the safety, tolerability and efficacy of ularitide in cirrhosis patients with refractory ascites.

Department of Hepatology and Gastroenterology, Aarhus University Hospital0 个研究点目标入组 38 人开始时间: 2020年1月10日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•- Age > 18 years
•- Liver cirrhosis confirmed by fibroscan (>20 kPa), or by imaging with signs of an irregular liver surface with collaterals, or clinically by cirrhosis stigmata
•- Refractory ascites: Definition: failure to respond to or intolerance to high dose diuretics (spironolactone up to 400mg/day and furosemide up to 160mg/day) and/or early ascites recurrence (reappearance of grade 2 or 3 ascites within 4 weeks of initial mobilization or =2 paracentesis within last 3 months)
•- Urine sodium excretion <60 mmol/24 hour
•- Serum creatinine <150 µmol/L
•- Child-Turcotte-Pugh score of B or C (<13)
•- Bilirubin <150 µmol/L
•- Systolic blood pressure =95 mmHg
•- Written informed consent to participate in the clinical trial
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 28
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- Gastrointestinal bleeding within 2 weeks prior to inclusion
•- Proteinuria >500 mg/day
•- Hemoglobin <5.5 mmol/L
•- Spontaneous bacterial peritonitis within 2 weeks prior to inclusion
•- Loculated ascites
•- Hepatic encephalopathy grade 2-4 (West-Haven classification)
•- Obstructive uropathy
•- Primary kidney disease
•- Known diagnosis of congestive heart failure
•- Known diagnosis of acute-on-chronic liver failure
•- Known diagnosis of systemic inflammatory response syndrome
•- Acute infections by known diagnosis and/or antibiotic treatment
•- Known HIV infection
•- Known allergy to the investigational drug or other natriuretic peptides
•- Treatment with dobutamine, levosimendan, milrinone, any phosphodiesterase inhibitor, octreotide, midodrine, vasopressin, dopamine or other vasopressors within 2 weeks prior to inclusion
•- Nephrotoxic drugs within 1 month prior to inclusion
•- Fertile women not using contraception, either an intrauterine device or hormonal contraception (tablets, implants, transdermal patches, vaginal rings and injections)
•- Positive pregnancy test in pre-menopausal women or in breast-feeding women. Menopause is defined as no menses since =12 months prior to screening
•- Participation in an interventional clinical drug trial within 1 month prior to inclusion
•- Legal incapacity or limited legal capacity
•- Patients who are employees or relatives of the investigator

发起方

Department of Hepatology and Gastroenterology, Aarhus University Hospital