Status:
COMPLETED
Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding
Lead Sponsor:
Debiovision
Conditions:
Esophageal Varices
Portal Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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. Cirrhot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00331188
Start Date
May 1 2006
End Date
July 1 2008
Last Update
July 8 2008
Active Locations (19)
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1
UAB Liver Center
Birmingham, Alabama, United States, 35294-0005
2
Alabama Liver & Digestive Specialists
Montgomery, Alabama, United States, 36116
3
Mayo Clinic
Scottsdale, Arizona, United States, 85054
4
University of California at San Diego
San Diego, California, United States, 92103-8707