Status:
TERMINATED
Refractory Ascites in Patients With Liver Cirrhosis, and the Potential Treatment With 48 Hours Infusion of Ularitide.
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
ADS AIPHIA Development Services AG
Conditions:
Cirrhosis, Liver
Ascites Hepatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This clinical trial intends to investigate the safety, tolerability and efficacy of ularitide on the renal response in patients with liver cirrhosis and refractory ascites for a maximum exposure durat...
Detailed Description
The investigators hypothesize that ularitide infusion is more effective than placebo to induce and maintain clinically meaningful natriuresis and diuresis in patients with liver cirrhosis and refracto...
Eligibility Criteria
Inclusion
- Men and women \>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 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
- Prothrombin time (PP) 0.20-0.60 (INR 1.3-2.5)
- Systolic blood pressure ≥95 mmHg
- Written informed consent to participate in the clinical trial
Exclusion
- 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
- Positive pregnancy test in pre-menopausal women or in breast-feeding women
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04311489
Start Date
August 1 2020
End Date
November 30 2022
Last Update
May 18 2023
Active Locations (1)
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1
Department of Hepatology and Gastroenterology, Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8200