Portal Hypertension Clinical Trial
Official title:
The Early Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding Due to Portal Hypertension
The main objective of this study is to determine the efficacy of early administration of Sanvar® in combination with endoscopic treatment for the control of acute variceal bleeding.
This is a single-arm open-label clinical study with historical controls using Sanvar®
(vapreotide) administered for 5 days in patients with acute variceal bleeding due to portal
hypertension.
Cirrhotic patients with a history of acute hematemesis and/or melena admitted to the
emergency unit and meeting the eligibility criteria will receive, as soon as possible after
admission (within a maximum of 24 hours after onset of hemorrhage and within 6 hours after
admission), Sanvar® (vapreotide acetate) 50 µg IV bolus followed by an IV continuous
infusion of 50 µg/h for 5 days.
The diagnostic and therapeutic endoscopy will be performed as soon as possible after the
initiation of the study drug infusion, but no more than 12 hours after the patient's
admission to the study center. A final follow up will be performed on Day 42.
Patients for whom the source of bleeding is determined at endoscopy to be due to a cause
other than portal hypertension (e.g. gastric ulcer) will be replaced. In addition, in such
cases the study medication will be discontinued and patients will receive standard treatment
according to the cause of their bleeding. These patients will be followed up for safety
only.
*Note: There is no provision in this study to have an expanded access program.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05052892 -
A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105)
|
||
Recruiting |
NCT05251272 -
A Combined Model Based on Spleen Stiffness, Liver Stiffness and Platelets for Assessing Portal Hypertension in Compensated Cirrhosis (CHESS2202)
|
||
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 | |
Recruiting |
NCT04578301 -
Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
|
||
Not yet recruiting |
NCT05515861 -
Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices
|
N/A | |
Recruiting |
NCT02364297 -
TIPS in Fundal Variceal Bleeding (the TFB Study)
|
N/A | |
Recruiting |
NCT01358123 -
Value of Von Willebrand Factor in Portal Hypertension
|
N/A | |
Completed |
NCT00493480 -
Danish Carvedilol Study in Portal Hypertension
|
Phase 3 | |
Recruiting |
NCT06266260 -
Evaluation of the Performance of Direct Portal Pressure Measurement by Endoscopic Ultrasound in a Large Cohort of Patients With Advanced Chronic Liver Disease of Different Etiologies and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP)
|
||
Recruiting |
NCT03277651 -
Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension
|
N/A | |
Active, not recruiting |
NCT03736265 -
Carvedilol for Prevention of Esophageal Varices Progression
|
N/A | |
Completed |
NCT03451149 -
Feasibility And Safety Of Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation Using A Radiofrequency Guidewire
|
N/A | |
Completed |
NCT02994485 -
Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin
|
Phase 4 | |
Completed |
NCT01923064 -
Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices
|
N/A | |
Completed |
NCT01851252 -
MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy
|
Phase 1 | |
Completed |
NCT01456286 -
Randomized Controlled Trial to Assess the Effects of Sapropterin on Hepatic and Systemic Hemodynamics in Patients With Liver Cirrhosis and Portal Hypertension
|
Phase 2/Phase 3 | |
Completed |
NCT01551966 -
Esophageal Capsule Endoscopy in Children
|
N/A | |
Completed |
NCT02344719 -
Effect of Taurine on Portal Hemodynamics in Patients With Advanced Liver Cirrhosis
|
Phase 4 | |
Recruiting |
NCT00414713 -
Transfusion Requirements in Gastrointestinal (GI) Bleeding
|
Phase 4 | |
Completed |
NCT00766805 -
Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis
|
N/A |