Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding
NCT ID: NCT00331188
Last Updated: 2008-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
70 participants
INTERVENTIONAL
2006-05-31
2008-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Sanvar® (vapreotide)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Debiovision
INDUSTRY
Responsible Party
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Debiovision
Principal Investigators
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Joseph Lim, M.D.
Role: STUDY_CHAIR
Yale University
Tarek Hassanein, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Michael B. Fallon, M.D.
Role: PRINCIPAL_INVESTIGATOR
UAB Liver Center, Division of Gastroenterology & Hepatology
Daniel R. Ganger, M.D.
Role: PRINCIPAL_INVESTIGATOR
Northwestern Memorial Hospital
Naga P. Chalasani, M.D.
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Adrian Reuben, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Paul J. Thuluvath, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Johns Hopkins Hospital & School of Medicine
James F. Trotter, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Hugo Vargas, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic Scottsdale, Arizona
Samuel Sigal, M.D.
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Michele D. Bishop, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic Jacksonville Florida
Gary A. Abrams, M.D.
Role: PRINCIPAL_INVESTIGATOR
Alabama Liver & Digestive Specialists Research Center - Montgomery, AB
Robert S. McFadden, M.D.
Role: PRINCIPAL_INVESTIGATOR
CHRISTUS Santa Rosa Medical Center - San Antonio, TX
Nezam H. Afdhal, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center, Boston MA
Jeffrey S. Crippin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Alvaro Koch, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky Medical Center - Lexington, KY
Kimberly Beavers, M.D., M. Ph.
Role: PRINCIPAL_INVESTIGATOR
Mission Hospitals, Inc. - Asheville, NC
Arun J. Sanyal, M.D.
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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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
Countries
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References
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Cales P, Masliah C, Bernard B, Garnier PP, Silvain C, Szostak-Talbodec N, Bronowicki JP, Ribard D, Botta-Fridlund D, Hillon P, Besseghir K, Lebrec D; French Club for the Study of Portal Hypertension. Early administration of vapreotide for variceal bleeding in patients with cirrhosis. N Engl J Med. 2001 Jan 4;344(1):23-8. doi: 10.1056/NEJM200101043440104.
Related Links
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N Engl J Med. 2001 Jan 4;344(1):23-8
Other Identifiers
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DEBV-VAP/EVB-301
Identifier Type: -
Identifier Source: org_study_id