Clinical trials: Ascites Hepatic
Portal Hypertension, Liver Diseases
Achieving Portal Access With Scorpion Post-Approval Study (APASS)
Creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a TIPS procedure.
- Conditions
- Portal Hypertension, Liver Diseases, Ascites Hepatic, Hydrothorax
- Trial name
- NCT05765253
- Testing
- Scorpion Portal Vein Access Kit, Cook Transjugular Liver Access Set, Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Argon Medical Devices
Ascites, Variceal Bleeding
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension.
- Conditions
- Ascites, Variceal Bleeding, Portal Hypertension Related to Cirrhosis
- Trial name
- VIATIPS (NCT07390344)
- Testing
- GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)
- Where
- 3 sites in United States
- Volunteers
- 152 people
- Sponsor
- W.L.Gore & Associates
Liver Cirrhosis
Comparing a Direct Versus an Indirect Approach to Measuring the Portalsytemic Pressure Gradients
The objective of this study is to evaluate the correlation of the calculated portosystemic pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the EchoTip® Insight™ and indirect portal vein…
- Trial name
- NCT04987034
- Testing
- EchoTip® Insight™
- Where
- 3 sites in Belgium, Netherlands and 1 more
- Volunteers
- 35 people
- Sponsor
- Cook Research Incorporated
Cirrhosis, Ascites Hepatic
Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites
Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.
- Trial name
- NCT03107091
- Testing
- Terlipressin acetate continuous infusion
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- BioVie Inc.
Acute-On-Chronic Liver Failure, Ascites
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and…
- Trial name
- NCT05900050
- Testing
- VS-01 on top of SOC, SOC (Control Group)
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 15 people
- Sponsor
- Genfit
Cirrhosis, Liver, Liver Fibrosis
Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
This 2-part study will evaluate PHIN-214 given as a single one-time dose (Part 1) and in multiple doses (given as daily doses for 28-days) (in Part 2).
- Conditions
- Cirrhosis, Liver, Liver Fibrosis, Ascites Hepatic
- Trial name
- NCT05490888
- Testing
- PHIN-214 Subcutaneous injection
- Where
- 9 sites in United States
- Volunteers
- 74 people
- Sponsor
- PharmaIN
Ascites Hepatic
A Study of OsrHSA in Adult Healthy Male and Female Volunteers
A Phase 1 randomized, double blinded, placebo-controlled single dose escalation study of OsrHSA in adult healthy male and female volunteers
- Trial name
- NCT04384523
- Testing
- OsrHSA 20 mg/kg IV, OsrHSA 40 mg/kg IV, OsrHSA 80 mg/kg IV
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Healthgen Biotechnology Corp.
Hepatic Ascites
A Study of Recombinant Human Albumin Injection to Treat Hypoalbuminemia in Cirrhotic Patients With Ascites
This study was a Phase III multicenter, blinded, and positive active-controlled clinical study to evaluate the efficacy, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia…
- Trial name
- NCT06911554
- Testing
- Recombinant Human Albumin Injection, Human Albumin
- Where
- China
- Volunteers
- 416 people
- Sponsor
- Tonghua Anrate Biopharmaceutical Co., Ltd.
Cirrhotic Ascites
Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites
This trial adopts random, double-blind, positive control, parallel group design to evaluate the effectiveness and safety of recombinant human serum albumin versus human serum albumin in hepatic cirrhosis patients with ascites.
- Trial name
- NCT06553456
- Testing
- Recombinant Human Serum Albumin, Human Serum Albumin
- Where
- 61 sites in China
- Volunteers
- 390 people
- Sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.
Portal Hypertension, TIPS
The BD Liverty™ TIPS Stent Graft Study
The objective of the study is to assess the safety and effectiveness of the BD Liverty™ TIPS Stent Graft for the treatment of the complications of portal hypertension from cirrhosis.
- Trial name
- ARCH (NCT05711316)
- Testing
- BD Liverty™ TIPS Stent Graft
- Where
- 26 sites in United States, France and 1 more
- Volunteers
- 177 people
- Sponsor
- C. R. Bard
Cirrhosis
A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema
OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and the change in body weight from baseline at…
- Trial name
- NCT01050530
- Testing
- OPC-41061
- Where
- 8 sites in Japan
- Volunteers
- 162 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Viral Hepatitis B, Viral Hepatitis D
Replicor Compassionate Access Program
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to…
- Conditions
- Viral Hepatitis B, Viral Hepatitis D, Cirrhosis, Liver, Decompensated Cirrhosis
- Trial name
- RCAP (NCT05683548)
- Testing
- REP 2139-Mg, Tenofovir Disoproxil Fumarate, Pegylated interferon alpha2a
- Where
- 13 sites in Austria, France and 3 more
- Sponsor
- Replicor Inc.
Cirrhosis, Ascites
Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.
Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.
- Trial name
- NCT00968695
- Testing
- Albumin
- Where
- 6 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Instituto Grifols, S.A.
Cirrhosis
A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema
To investigate the dose response for changes from baseline in body weight as a primary endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb edema, and pleural effusion as secondary endpoints in…
- Trial name
- NCT00479336
- Testing
- OPC-41061 7.5mg, OPC-41061 15mg, OPC-41601 30mg
- Where
- 7 sites in Japan
- Volunteers
- 104 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Portal Hypertension, Liver Diseases
Achieving Portal Access With Scorpion Post-Approval Study 2
Creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a TIPS procedure.
- Conditions
- Portal Hypertension, Liver Diseases, Ascites Hepatic, Hydrothorax
- Trial name
- APASS2 (NCT06856655)
- Testing
- Scorpion Portal Vein Access Kit
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Argon Medical Devices
Hepatic Ascites
Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects
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…
- Trial name
- NCT05249374
- Testing
- Recombinant Human Serum Albumin, Human serum albumin
- Where
- 8 sites in China
- Volunteers
- 36 people
- Sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.
Cirrhotic Ascites
Phase II/III of Recombinant Human Serum Albumin
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.
- Trial name
- NCT05858853
- Testing
- Recombinant Human Serum Albumin, Human serum albumin
- Where
- 25 sites in China
- Volunteers
- 92 people
- Sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.
Cirrhosis
A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg
OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with ascites despite having received conventional diuretic therapy.
- Trial name
- NCT01048788
- Testing
- OPC-41061
- Where
- 6 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Liver Cirrhosis, Portal Hypertension
Early TIPS for Ascites Study
The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver with portal hypertension and…
- Conditions
- Liver Cirrhosis, Portal Hypertension, Ascites
- Trial name
- NCT01236339
- Testing
- TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis, LVP, TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates
Hepatic Ascites
Recombinant Human Serum Albumin in Healthy Subjects
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…
- Trial name
- NCT05179265
- Testing
- recombinant human serum albumin, Human serum albumin
- Where
- 2 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.