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.
Drug: Sanvar® (vapreotide)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Early Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding Due to Portal Hypertension|
- To determine the efficacy of the early administration of Sanvar® (vapreotide) in association with endoscopic treatment for the control of bleeding at 5 days, i.e. control of initial bleeding and prevention of early re-bleeding, plus survival. [ Time Frame: 5 days ]
- To assess the following:
- The effect of drug administration before endoscopy assessed by the endoscopic facilitation and control of bleeding at endoscopy, [ Time Frame: Endoscopy ]
- Control of bleeding 6 hours after infusion of the study drug (= Tinf + 6h), [ Time Frame: Tinf + 6h ]
- Control of bleeding by time periods (Tendo+6h, Tendo+48h and Tendo+ 120h) by Child Pugh class, [ Time Frame: Tendo+6h, Tendo+48h and Tendo+ 120h ]
- Number of blood units administered during the 5 days of drug infusion, [ Time Frame: 5 days ]
- Safety of treatment [ Time Frame: 42 days ]
|Study Start Date:||May 2006|
|Study Completion Date:||July 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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.
Show 19 Study Locations
|Study Chair:||Joseph Lim, M.D.||Yale University|
|Principal Investigator:||Tarek Hassanein, M.D.||University of California, San Diego|
|Principal Investigator:||Michael B. Fallon, M.D.||UAB Liver Center, Division of Gastroenterology & Hepatology|
|Principal Investigator:||Daniel R. Ganger, M.D.||Northwestern Memorial Hospital|
|Principal Investigator:||Naga P. Chalasani, M.D.||Indiana University School of Medicine|
|Principal Investigator:||Adrian Reuben, M.D.||Medical University of South Carolina|
|Principal Investigator:||Paul J. Thuluvath, M.D.||The Johns Hopkins Hospital & School of Medicine|
|Principal Investigator:||James F. Trotter, M.D.||University of Colorado, Denver|
|Principal Investigator:||Hugo Vargas, M.D.||Mayo Clinic Scottsdale, Arizona|
|Principal Investigator:||Samuel Sigal, M.D.||Weill Medical College of Cornell University|
|Principal Investigator:||Michele D. Bishop, M.D.||Mayo Clinic Jacksonville Florida|
|Principal Investigator:||Gary A. Abrams, M.D.||Alabama Liver & Digestive Specialists Research Center - Montgomery, AB|
|Principal Investigator:||Robert S. McFadden, M.D.||CHRISTUS Santa Rosa Medical Center - San Antonio, TX|
|Principal Investigator:||Nezam H. Afdhal, M.D.||Beth Israel Deaconess Medical Center - Boston, MA|
|Principal Investigator:||Jeffrey S. Crippin, M.D.||Washington University School of Medicine|
|Principal Investigator:||Alvaro Koch, M.D.||University of Kentucky Medical Center - Lexington, KY|
|Principal Investigator:||Kimberly Beavers, M.D., M. Ph.||Mission Hospitals, Inc. - Asheville, NC|
|Principal Investigator:||Arun J. Sanyal, M.D.||Virginia Commonwealth University|