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

NCT00331188 | Completed Phase 3

• 1 other identifier: DEBV-VAP/EVB-301
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 19

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.

Conditions

Esophageal Varices; Portal Hypertension; Gastric Varices; Esophageal Bleeding

Keywords

Esophageal Variceal Bleeding; Portal Hypertension; Hepatic Cirrhosis; Cirrhosis; Liver Cirrhosis; Somatostatin Analog; Vapreotide; Acute Esophageal Variceal Bleeding

Outcome Measures

Primary Outcomes (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.

  5 days

Secondary Outcomes (6)

• To assess the following:

• The effect of drug administration before endoscopy assessed by the endoscopic facilitation and control of bleeding at endoscopy,

  Endoscopy

• Control of bleeding 6 hours after infusion of the study drug (= Tinf + 6h),

  Tinf + 6h

• Control of bleeding by time periods (Tendo+6h, Tendo+48h and Tendo+ 120h) by Child Pugh class,

  Tendo+6h, Tendo+48h and Tendo+ 120h

• Number of blood units administered during the 5 days of drug infusion,

  5 days

Interventions

Sanvar® (vapreotide) DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Debiovision: lead

Study Sites (19)

UAB Liver Center

Birmingham, Alabama, 35294-0005, United States

Location

Alabama Liver & Digestive Specialists

Montgomery, Alabama, 36116, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85054, United States

Location

University of California at San Diego

San Diego, California, 92103-8707, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Northwestern University, The Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins Hospital & School of Medicine, Div. of Gastroenterology & Hepatology

Baltimore, Maryland, 21205, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Mission Hospitals, Inc.

Asheville, North Carolina, 28801, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

CHRISTUS Santa Rosa Medical Center

San Antonio, Texas, 78229, United States

Location

Virginia Commonwealth University MCV Campus West Hospital

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 11136956 BACKGROUND

Related Links

• N Engl J Med. 2001 Jan 4;344(1):23-8

MeSH Terms

Conditions

Esophageal and Gastric Varices; Hypertension, Portal; Liver Cirrhosis; Fibrosis

Interventions

vapreotide

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Lim, M.D.

  Yale University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2006
• First Posted: May 29, 2006
• Study Start: May 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 8, 2008

Record last verified: 2008-07

Locations

US (19)