Ascites Clinical Trial
Official title:
A Phase 2 Randomized, Dose-Titration, Open-Label Study Evaluating the Safety and Efficacy of BIV201 Compared to Standard of Care to Reduce Ascites and Complications in Cirrhotic Patients With 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 with refractory ascites secondary to decompensated cirrhosis
Terlipressin has been shown to reduce portal hypertension, improve renal function and induce natriuresis in cirrhotic patients with ascites without hepatorenal syndrome (HRS). It is approved in Europe for the treatment of bleeding esophageal varices and HRS type 1 and is usually administered as an IV bolus starting at 1 mg every 6 h and increased to 2 mg every 6 h (maximum 8 mg/day depending on response). This study will evaluate the use of terlipressin delivered by continuous infusion for two 28 day treatment cycles for reduction of ascites accumulation and complications in adult patients with refractory ascites secondary to decompensated cirrhosis. Continuous infusion allows for a significant reduction in the daily effective dose required for treatment and improved safety of terlipressin delivered as a low-dose continuous infusion could enable its use in the outpatient setting in the prolonged treatment of patients with refractory ascites. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02891642 -
Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
|
||
Recruiting |
NCT00239096 -
Prevention of Decompensation in Liver Cirrhosis
|
Phase 4 | |
Active, not recruiting |
NCT03973866 -
Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)
|
N/A | |
Completed |
NCT01349348 -
Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites
|
Phase 3 | |
Terminated |
NCT01455246 -
Daptomycin + Meropenem Versus Ceftazidime in the Treatment of Nosocomial Spontaneous Bacterial Peritonitis
|
Phase 2/Phase 3 | |
Completed |
NCT01578226 -
Procalcitonin in Cirrhotic Patients at High Risk for Sepsis
|
N/A | |
Terminated |
NCT00548366 -
Sodium Restriction in the Management of Cirrhotic Ascites
|
Phase 4 | |
Recruiting |
NCT05025878 -
13C-Glucose Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients.
|
||
Completed |
NCT03327688 -
Point-of-care Ultrasound in Finland
|
N/A | |
Not yet recruiting |
NCT04550091 -
Role Of Multi-detector Computed Tomography In Differentiation Between Different Types Of Ascites
|
||
Not yet recruiting |
NCT01716611 -
Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites
|
Phase 4 | |
Completed |
NCT01769040 -
Intestinal Decontamination With Rifaximin. The Inflammatory and Circulatory State in Patients With Cirrhosis
|
Phase 4 | |
Recruiting |
NCT05700708 -
Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
|
||
Recruiting |
NCT05511766 -
Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis
|
Phase 2/Phase 3 | |
Completed |
NCT05013502 -
Empagliflozin in Diuretic Refractory Ascites
|
Phase 1 | |
Not yet recruiting |
NCT06436807 -
PMCF Study of the CE-marked Drainova® ArgentiC Catheter
|
||
Completed |
NCT03263598 -
Validation of Diagnostic Usefulness of the Random Urine Na/K Ratio for Replacement of 24hr Urine Na Excretion in Cirrhotic Patients With Ascites
|
||
Completed |
NCT00907673 -
The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure
|
N/A | |
Terminated |
NCT00796861 -
Trial of Sunitinib for Refractory Malignant Ascites
|
Phase 2 | |
Suspended |
NCT00511394 -
Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis
|
N/A |