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

This study has been completed.
Sponsor:
Information provided by:
Debiovision
ClinicalTrials.gov Identifier:
NCT00331188
First received: May 26, 2006
Last updated: July 7, 2008
Last verified: July 2008
  Purpose

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 Intervention Phase
Esophageal Varices
Portal Hypertension
Gastric Varices
Esophageal Bleeding
Drug: Sanvar® (vapreotide)
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Debiovision:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 70
Study Start Date: May 2006
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331188

  Show 19 Study Locations
Sponsors and Collaborators
Debiovision
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Marco Petrella, M.Sc., Ph.D. - Director, Clinical Affairs & New Product Development, Debiovision
ClinicalTrials.gov Identifier: NCT00331188     History of Changes
Other Study ID Numbers: DEBV-VAP/EVB-301
Study First Received: May 26, 2006
Last Updated: July 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Debiovision:
Esophageal Variceal Bleeding
Portal Hypertension
Hepatic Cirrhosis
Cirrhosis
Liver Cirrhosis
Somatostatin Analog
Vapreotide
Acute Esophageal Variceal Bleeding

Additional relevant MeSH terms:
Hypertension
Hemorrhage
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Vapreotide
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014