Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding
- Conditions
- Esophageal VaricesPortal HypertensionGastric VaricesEsophageal Bleeding
- Registration Number
- NCT00331188
- Lead Sponsor
- Debiovision
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Female or male cirrhotic patient aged 18 to 75 years.
- Hematemesis and/or melena (suspected to be caused by portal hypertension)
- Time interval <=24 hours between onset of initial hemorrhage and initiation of study drug infusion.
- Time interval <=6 hours between admission and initiation of study drug infusion.
- Anticipated time interval<=12 hours between admission and end of therapeutic endoscopy.
- Unequivocal history of cirrhosis, either documented by at least one of classical clinical signs (abdominal collateral venous circulation, firm liver with a sharp lower liver edge, presence of spider naevi, and/or ascites), or by biochemical and/or Doppler-US signs.
- Written informed consent obtained by the patient or his/her relative(s)
- Patient previously included in this study for a prior bleeding episode.
- Patients treated with a vasoactive drug such as octreotide, vasopressin or its analogue for the current episode of bleeding.
- Hepatic encephalopathy Grade IV.
- Balloon tamponade already positioned at admission.
- Known Child-Pugh score >=13
- Pregnant or breast-feeding women.
- Known diffuse hepatocellular carcinoma.
- Known complete portal venous thrombosis.
- Bleeding from esophageal varices within the previous 6 weeks.
- Patient currently enrolled in another therapeutic study, and/or who participated in another clinical study, within the previous 6 weeks.
- Known allergy to somatostatin or somatostatin analogues.
- Previous porto-systemic shunt (TIPS) or orthotopic liver transplantation.
- Patient with known cancer.
- Patient with known chronic renal failure (serum creatinine > 1.5 mg/dl).
- Severe concomitant disease judged by the Investigator as being incompatible with evaluation of treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine the efficacy of the early administration of Sanvar® (vapreotide) in association with endoscopic treatment for the control of bleeding at 5 days, i.e. control of initial bleeding and prevention of early re-bleeding, plus survival. 5 days
- Secondary Outcome Measures
Name Time Method To assess the following: The effect of drug administration before endoscopy assessed by the endoscopic facilitation and control of bleeding at endoscopy, Endoscopy Control of bleeding 6 hours after infusion of the study drug (= Tinf + 6h), Tinf + 6h Control of bleeding by time periods (Tendo+6h, Tendo+48h and Tendo+ 120h) by Child Pugh class, Tendo+6h, Tendo+48h and Tendo+ 120h Number of blood units administered during the 5 days of drug infusion, 5 days Safety of treatment 42 days
Trial Locations
- Locations (18)
Mission Hospitals, Inc.
🇺🇸Asheville, North Carolina, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Johns Hopkins Hospital & School of Medicine, Div. of Gastroenterology & Hepatology
🇺🇸Baltimore, Maryland, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Virginia Commonwealth University MCV Campus West Hospital
🇺🇸Richmond, Virginia, United States
Alabama Liver & Digestive Specialists
🇺🇸Montgomery, Alabama, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
UAB Liver Center
🇺🇸Birmingham, Alabama, United States
Northwestern University, The Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of California at San Diego
🇺🇸San Diego, California, United States
CHRISTUS Santa Rosa Medical Center
🇺🇸San Antonio, Texas, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States