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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00331188
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : July 8, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Esophageal Varices Portal Hypertension Gastric Varices Esophageal Bleeding Drug: Sanvar® (vapreotide) Phase 3

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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To assess the following:
  2. The effect of drug administration before endoscopy assessed by the endoscopic facilitation and control of bleeding at endoscopy, [ Time Frame: Endoscopy ]
  3. Control of bleeding 6 hours after infusion of the study drug (= Tinf + 6h), [ Time Frame: Tinf + 6h ]
  4. 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 ]
  5. Number of blood units administered during the 5 days of drug infusion, [ Time Frame: 5 days ]
  6. Safety of treatment [ Time Frame: 42 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00331188

Show Show 19 study locations
Sponsors and Collaborators
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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
Additional Information:
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Responsible Party: Marco Petrella, M.Sc., Ph.D. - Director, Clinical Affairs & New Product Development, Debiovision Identifier: NCT00331188    
Other Study ID Numbers: DEBV-VAP/EVB-301
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: July 8, 2008
Last Verified: July 2008
Keywords provided by Debiovision:
Esophageal Variceal Bleeding
Portal Hypertension
Hepatic Cirrhosis
Liver Cirrhosis
Somatostatin Analog
Acute Esophageal Variceal Bleeding
Additional relevant MeSH terms:
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Hypertension, Portal
Esophageal and Gastric Varices
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents