Clinical trials: Decompensated Cirrhosis and Ascites
Ascites, Liver Cirrhosis
Proximal Splenic Artery Embolization (PSAE) for the Treatment of Refractory Ascites in Decompensated Cirrhosis
The purpose of this study is to learn whether a procedure called Proximal Splenic Artery Embolization (PSAE) can lower the need for repeat fluid drainage in adults with cirrhosis and a buildup of fluid in the abdomen (ascites)…
- Conditions
- Ascites, Liver Cirrhosis, Hypertension, Portal
- Trial name
- NCT07755059
- Testing
- Proximal Splenic Artery Embolization
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Massachusetts General Hospital
Cirrhosis, Portal Hypertension
A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
Endothelin is a human hormone which has been associated with increased portal pressure in patients with liver cirrhosis (also called portal hypertension). Ambrisentan blocks the effects of endothelin.
- Conditions
- Cirrhosis, Portal Hypertension, Ascites
- Trial name
- NCT03827200
- Testing
- Ambrisentan
- Where
- 6 sites in Spain
- Volunteers
- 19 people
- Sponsor
- Noorik Biopharmaceuticals AG
Decompensated Liver Cirrhosis
TIPS in Patients With Decompensated Liver Cirrhosis
This is a single center patient registry of patients receiving a transjugular intrahepatic portosystemic shunt (TIPS) at Hannover Medical School.
- Trial name
- NCT04801290
- Testing
- TIPS insertion
- Where
- Germany
- Volunteers
- 250 people
- Sponsor
- Hannover Medical School
Liver Cirrhosis
Evaluation of Albumin and Midodrine Versus Albumin Alone in Outcome of Refractory Ascites in Patients With Decompensated Cirrhosis.
The project is about evaluation of albumin and midodrine versus albumin alone in outcome of refractory ascites in patients with decompensated cirrhosis. Cirrhosis is a leading cause of disability and mortality worldwide.
- Trial name
- NCT04816240
- Testing
- Midodrine, Albumin, Standard Medical Treatment
- Where
- India
- Volunteers
- 200 people
- Sponsor
- Institute of Liver and Biliary Sciences, India
Decompensated Cirrhosis
Efficacy of Targeted And Response-Guided Albumin Therapy Versus Standard Medical Treatment In Outcomes Of Recurrent Ascites In Patients With Decompensated Cirrhosis.
The current prospective randomized controlled trial would aim to study the efficacy of targeted albumin therapy versus standard medical treatment in reduction in 6-month mortality in recurrent ascites in patients with…
- Trial name
- NCT04679571
- Testing
- Albumin, Standard Medical Treatment
- Where
- India
- Volunteers
- 100 people
- Sponsor
- Institute of Liver and Biliary Sciences, India
Decompensated Cirrhosis
Evaluation of Low-dose Albumin and Midodrine Versus Midodrine Alone in Outcome of Recurrent Ascites in Patients With Decompensated Cirrhosis.
The project is about evaluation of albumin and midodrine versus midodrine alone in outcome of recurrent ascites in patients with decompensated cirrhosis. Cirrhosis occcurs in 50% of patients over 10 years.
- Trial name
- NCT06245590
- Testing
- Albumin, Midodrine, Standard of Care
- Where
- 2 sites in India
- Volunteers
- 100 people
- Sponsor
- Institute of Liver and Biliary Sciences, India
Cirrhosis, Ascites
Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis
Cirrhosis is frequently complicated by derangement of body fluid homeostasis resulting in accumulation of large amounts of extracellular fluid in the peritoneal cavity (ascites) and interstitial tissue (edema).
- Trial name
- NCT00511394
- Testing
- 20% Human Albumin, Normal Saline
- Where
- India
- Volunteers
- 16 people
- Sponsor
- Govind Ballabh Pant Hospital
Decompensated Cirrhosis and Ascites
Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in participants…
- Trial name
- PRECIOSA (NCT03451292)
- Testing
- Albutein 20%, SMT
- Where
- 66 sites in United States, Belgium and 12 more
- Volunteers
- 410 people
- Sponsor
- Grifols Therapeutics LLC
Decompensated Cirrhosis
To Develop and Validate an Equation for Determination of Major Adverse Kidney Events in Patients With Decompensated Cirrhosis and Ascites.
Acute kidney injury (AKI) is the sudden loss of kidney function that occurs frequently in hospitalised patients with cirrhosis. It develops in up to 53% and is independently associated with high short-term mortality.
- Trial name
- NCT07794787
- Where
- India
- Volunteers
- 400 people
- Sponsor
- Institute of Liver and Biliary Sciences, India
Decompensated Cirrhosis, Portal Hypertension
The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS
The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure.
- Conditions
- Decompensated Cirrhosis, Portal Hypertension, Bleeding Varices, Refractory Ascites
- Trial name
- NCT01440829
- Testing
- L-ornithine-L-aspartate
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Air Force Military Medical University, China
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.
Liver Cirrhoses
Concordance Between Echocardiographic Assessment Performed in the Initial Phase of Decompensated Cirrhosis With Edema and Ascites by an Expert Intensive Care Physician and a Non-expert Gastroenterologist
The investigators hypothesize that trans-thoracic ultrasound performed by non-specialist gastroenterologists with a standard training by intensive care doctors will give equivalent results to those achieved by experts for a…
- Trial name
- EchoCirrho (NCT03650660)
- Testing
- Trans-thoracic ultrasound
- Where
- France
- Volunteers
- 55 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Caregivers
CAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
The goal of this study is to enroll caretakers of patients with decompensated cirrhosis to determine if written emotional disclosure or resilience training interventions reduce distress and burden among primary informal…
- Trial name
- NCT04205396
- Testing
- Written emotional disclosure, Resilience training, No treatment
- Where
- United States
- Volunteers
- 87 people
- Sponsor
- University of Michigan
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
Ascites
Comparison of Crystalloid and Colloid I.V Fluid Therapy in Prevention of Paracentesis Induced Circulatory Dysfunction (PICD) and Renal Dysfunction in Patients With Decompensated Liver Cirrhosis in Egypt: a Randomized Piolet Study
2.2 Aim(s) of the Research (50 words max): To Compare between crystalloid and colloid I.V fluid therapy in the prevention of paracentesis induced circulatory dysfunction (PICD) and renal dysfunction in patients with decompensated…
- Trial name
- NCT05220891
- Testing
- Paracentesis
- Volunteers
- 60 people
- Sponsor
- Shady Ashraf Kassem
Cirrhosis of the Liver, Ascites
Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites
This protocol represents an open-label pilot study to assess whether oral administration of SBI in subjects with decompensated cirrhosis with ascites can lead improvements in the management of the disease.
- Conditions
- Cirrhosis of the Liver, Ascites, Spontaneous Bacterial Peritonitis
- Trial name
- NCT02608658
- Testing
- Medical food, EnteraGam (Serum-Derived Bovine Immunoglobulin)
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- St. Louis University
Cirrhosis, Liver, Portal Hypertension
A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients
This is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.
- Conditions
- Cirrhosis, Liver, Portal Hypertension, Ascites Hepatic
- Trial name
- WATCH (NCT05928624)
- Testing
- Withings Home Blood Pressure Device and Scale, Standard of Care
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- University of California, San Francisco
Liver Cirrhosis
Study in Patients With Decompensated Liver Cirrhosis
OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis.
- Trial name
- OPAL (NCT06380335)
- Where
- 12 sites in Spain, United Kingdom
- Volunteers
- 24 people
- Sponsor
- Resolution Therapeutics Limited
Antibiotic Toxicity, Liver Cirrhosis
A Study to Determine Pharmacokinetic Changes of Ceftriaxone in Patients With Liver Cirrhosis
The investigators designed an observational multicenter explorative in vivo study to investigate the changes in ceftriaxone pharmacokinetics in blood and ascites.
- Conditions
- Antibiotic Toxicity, Liver Cirrhosis, Renal Insufficiency, Ceftriaxone Overdose
- Trial name
- TACTILE (NCT05960006)
- Testing
- No intervention (observational study)
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Ascites, Decompensated Cirrhosis
A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites
This study evaluates the addition of BIV201 (terlipressin diacetate) as a continuous infusion in addition to standard of care (diuretics and therapeutic paracentesis) for reduction of ascites and complications in adult patients…
- Trial name
- NCT04112199
- Testing
- BIV201 continuous infusion
- Where
- 10 sites in United States
- Volunteers
- 15 people
- Sponsor
- BioVie Inc.