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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Sanvar® (vapreotide)

About this trial

This is an interventional treatment trial for Esophageal Varices focused on measuring Esophageal Variceal Bleeding, Portal Hypertension, Hepatic Cirrhosis, Cirrhosis, Liver Cirrhosis, Somatostatin Analog, Vapreotide, Acute Esophageal Variceal Bleeding

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UAB Liver Center
Alabama Liver & Digestive Specialists
Mayo Clinic
University of California at San Diego
University of Colorado Health Sciences Center
Yale University School of Medicine
Mayo Clinic
Northwestern University, The Feinberg School of Medicine
Indiana University School of Medicine
University of Kentucky Medical Center
Johns Hopkins Hospital & School of Medicine, Div. of Gastroenterology & Hepatology
Beth Israel Deaconess Medical Center
Washington University School of Medicine
Weill Medical College of Cornell University
Columbia University Medical Center
Mission Hospitals, Inc.
Medical University of South Carolina
CHRISTUS Santa Rosa Medical Center
Virginia Commonwealth University MCV Campus West Hospital

Outcomes

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.

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,

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

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

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

Safety of treatment

Full Information

NCT ID

NCT00331188

First Posted

May 26, 2006

Last Updated

July 7, 2008

Sponsor

Debiovision

1. Study Identification

Unique Protocol Identification Number

NCT00331188

Brief Title

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

Official Title

The Early Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding Due to Portal Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Debiovision

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Sanvar® (vapreotide)

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

To assess the following:

Title

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

Time Frame

Endoscopy

Title

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

Time Frame

Tinf + 6h

Title

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

Title

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

Time Frame

5 days

Title

Safety of treatment

Time Frame

42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials: