Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding
Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding
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.
Inclusion Criteria:

 -  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)

 Exclusion Criteria:

 -  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.