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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Debiovision
• Treatments: Vapreotide

Criteria

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.