Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding

Completed · Phase 3

Conditions studied: Esophageal Varices, Portal Hypertension, Gastric Varices, Esophageal Bleeding

In brief

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.

Key facts

Study ID: NCT00331188
Run by: Debiovision
People needed: 70
Starts: 2006-05-01
Expected to finish: 2008-07-01
Last updated by the study team: 2008-07-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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.

Where it is running

UAB Liver Center — Birmingham, Alabama, United States
Alabama Liver & Digestive Specialists — Montgomery, Alabama, United States
Mayo Clinic — Scottsdale, Arizona, United States
University of California at San Diego — San Diego, California, United States
University of Colorado Health Sciences Center — Denver, Colorado, United States
Yale University School of Medicine — New Haven, Connecticut, United States
Mayo Clinic — Jacksonville, Florida, United States
Northwestern University, The Feinberg School of Medicine — Chicago, Illinois, United States
Indiana University School of Medicine — Indianapolis, Indiana, United States
University of Kentucky Medical Center — Lexington, Kentucky, United States
Johns Hopkins Hospital & School of Medicine, Div. of Gastroenterology & Hepatology — Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Washington University School of Medicine — St Louis, Missouri, United States
Weill Medical College of Cornell University — New York, New York, United States
Columbia University Medical Center — New York, New York, United States
Mission Hospitals, Inc. — Asheville, North Carolina, United States
Medical University of South Carolina — Charleston, South Carolina, United States
CHRISTUS Santa Rosa Medical Center — San Antonio, Texas, United States
Virginia Commonwealth University MCV Campus West Hospital — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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