Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331188
Status:
COMPLETED
Last Update Posted:
2008-07-08
First Post:
2006-05-26
Brief Title:
Use of Sanvar With Endoscopic Treatment for the Control of Acute Variceal Bleeding
Sponsor:
Debiovision
Organization:
Debiovision
Study Overview
Official Title:
The Early Use of Sanvar With Endoscopic Treatment for the Control of Acute Variceal Bleeding Due to Portal Hypertension
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 µgh 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 patients 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 eg 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
Cirrhotic patients with a history of acute hematemesis andor 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 µgh 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 patients 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None