Clinical Trials Logo
  1. Home
  2. Cirrhosis, Liver
  3. NCT04311489

Refractory Ascites in Patients With Liver Cirrhosis, and the Potential Treatment With 48 Hours Infusion of Ularitide. — ULA04  

Cirrhosis, Liver Clinical Trial

Official title:
Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Safety, Tolerability and Efficacy of Ularitide in Cirrhosis Patients With Refractory Ascites.

Clinical Trial 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 duration of 48 hours, through a randomized, placebo-controlled, double-blind, single-center trial.

Clinical Trial 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 refractory ascites. Participants will be given ularitide or placebo intravenously while hospitalized at Department of Hepatology and Gastroenterology at Aarhus University Hospital. During the hospitalization blood and urine samples are frequently collected. 30 ng/kg/min is the starting dosage for all participants. Depending on effects and/or side effects, ULA04 is designed to individualize treatment doses by up- and/or downtitration of the infusion dose within a predefined dose range. Relevant safety precautions are incorporated in the study design and treatment will be prematurely discontinued if a pre-defined stopping criteria presents. Patients will be followed up for the appearance of serious adverse events 30 days after the treatment. If a separate written consent is given by the participants, additional blood and urine samples will be collected and stored in a biobank for future research. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04311489
Study type Interventional
Source University of Aarhus
Contact
Status Terminated
Phase Phase 2
Start date August 1, 2020
Completion date November 30, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05793983 - S100A8/A9 and Innate Immunity in Liver Disease
Completed NCT04604860 - Use of EL-FIT App to Promote Physical Activity N/A
Recruiting NCT05928624 - A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients N/A
Active, not recruiting NCT01438970 - Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function Phase 2
Recruiting NCT05998330 - LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease N/A
Completed NCT04581369 - Cirrhosis Medical Home N/A
Withdrawn NCT04244877 - Rifaximin's Effect on Covert Hepatic Encephalopathy With SIBO and Gastrointestinal Dysmotility Phase 3
Recruiting NCT04588077 - Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis Phase 4
Recruiting NCT05538962 - Longitudinal Monitoring of Inflammation in Cirrhosis N/A
Completed NCT04082780 - Rifamycin in Minimal Hepatic Encephalopathy Phase 2
Completed NCT03850977 - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Active, not recruiting NCT03736265 - Carvedilol for Prevention of Esophageal Varices Progression N/A
Recruiting NCT04530760 - Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation
Recruiting NCT05093218 - Effect of Branch Chain Amino Acid Therapy on Sarcopenia in Children With Chronic Liver Disease. N/A
Recruiting NCT03437876 - Study on Effect of Intestinal Microbiota Transplantation in Hepatitis B Virus Induced Cirrhosis N/A
Recruiting NCT05604274 - Longitudinal Monitoring of Stool Characteristics
Recruiting NCT04867954 - Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
Completed NCT04643795 - Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects Phase 1
Active, not recruiting NCT02344680 - Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
Completed NCT04121520 - Perioperative Care of HVPG Measurement (CHESS1904): An International Multicenter Survey