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Ascites clinical trials

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NCT ID: NCT06411743 Completed - Hepatic Ascites Clinical Trials

Phase II/III of Recombinant Human Albumin Injection

Start date: September 7, 2021
Phase: Phase 2
Study type: Interventional

This study was a Phase II/III multicenter, blinded, and positiveactive-controlled clinical study with seamless adaptive design to evaluate the dose-response relationship, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites, and to provide a reference for the design of the Phase III clinical study.

NCT ID: NCT06196723 Completed - Refractory Ascites Clinical Trials

Early Transjugular Intrahepatic Portosystemic Shunts Improve Survival in Patients With Cirrhosis and Recurrent Ascites

TIPS
Start date: December 1, 2023
Phase:
Study type: Observational

Currently, there is limited evidence regarding the survival benefit of early transjugular intrahepatic portal shunt (TIPS) placement in patients with cirrhosis and recurrent ascites. This observational study aimed to assess whether early TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites. We will compare large volume paracenteses plus albumin (LVP+A) to see if TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites.

NCT ID: NCT05858853 Completed - Hepatic Ascites Clinical Trials

Phase II/III of Recombinant Human Serum Albumin

Start date: May 25, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, double-blind, position-controlled, parallel group phase II/III clinical study of recombinant human serum albumin (rHSA) in cirrhotic ascites patients.

NCT ID: NCT05621005 Completed - Ascites Infection Clinical Trials

Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients

Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

Norfloxacin is the most commonly used drug for the prophylaxis against spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis. Rifaximin, another broad spectrum antibiotic with only trivial absorption from the gut, is used for the treatment of traveler's diarrhea and prevention of hepatic encephalopathy.

NCT ID: NCT05430243 Completed - Ascites Hepatic Clinical Trials

Empagliflozin as a Novel Therapy in Refractory Ascites

Start date: April 21, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the present study is to investigate the safety, efficacy and cost-effectiveness of empagliflozin, a sodium glucose transporter 2 inhibitor, as an add on therapy to the standard care for refractory ascites in patients with liver cirrhosis

NCT ID: NCT05309200 Completed - Acute Kidney Injury Clinical Trials

A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury

Start date: April 28, 2022
Phase: Phase 2
Study type: Interventional

OCE-205 is being tested to treat participants who have developed Hepatorenal Syndrome-Acute Kidney Injury as a complication of cirrhosis with ascites. The study aims are to evaluate the safety and efficacy of OCE-205 at various doses. Participants will receive treatment by intravenous infusion. Participants will continue with this treatment until participants meets primary endpoint or any discontinuation criteria.

NCT ID: NCT05249374 Completed - Hepatic Ascites Clinical Trials

Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects

Start date: October 14, 2021
Phase: Phase 1
Study type: Interventional

This trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary effectiveness of recombinant human serum albumin in patients with liver cirrhosis and ascites subjects (both male and female) were screened and enrolled to the three dose levels of 10g, 20 g,and 30 g according to the principle of dose escalation, and 8 out of 12 subjects in each dose group One patient received the test drug, and 4 received a positive drug.

NCT ID: NCT05179265 Completed - Hepatic Ascites Clinical Trials

Recombinant Human Serum Albumin in Healthy Subjects

Start date: March 29, 2021
Phase: Phase 1
Study type: Interventional

This trial adopts a single-center, randomized, double-blind, dose-escalation, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single administration of recombinant human serum albumin in healthy subjects Kinetics and anti-drug antibody characteristics. Qualified healthy subjects (both male and female) were screened and enrolled to the four dose levels of 2 g, 5 g, 10 g, and 20 g according to the principle of dose escalation, and 6 out of 8 subjects in each dose group One patient received the test drug, and two received a placebo.

NCT ID: NCT05013502 Completed - Liver Cirrhosis Clinical Trials

Empagliflozin in Diuretic Refractory Ascites

DRAin-Em 01
Start date: November 15, 2021
Phase: Phase 1
Study type: Interventional

Ascites is the most frequent complication of liver cirrhosis and results in increased morbidity and mortality but current medical management options are limited. Here, the investigators will conduct an interventional single-arm pilot clinical trial toevaluate the feasibility of empagliflozin in managing diuretic-resistant ascites in patients with decompensated cirrhosis. This single site, open label pilot study will enroll participants with decompensated cirrhosis at a single site. Participants will receive empagliflozin 10mg oral tablets once daily for 12 weeks with monitoring for safety and adverse events.

NCT ID: NCT04785755 Completed - Hepatic Ascites Clinical Trials

Effects of Adding Hypertonic Saline Solutions and/or Etilefrine to Standard Diuretics Therapy in Hepatic Ascites

Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

This work aimed to evaluate and compare the impact of adding hypertonic saline solution (HSS) infusion and/or etilefrine to oral diuretics therapy on clinical outcomes, renal and systemic hemodynamics, metabolic and inflammatory pathways by estimating the changes in selected biological markers in cirrhotic patients with ascites. Also, the trial aims to assess the safety and tolerability of such treatment regimens.