Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287664
Status:
SUSPENDED
Last Update Posted:
2007-04-11
First Post:
2006-02-03
Brief Title:
Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome Effect on Survival and Renal Function Multicenter Randomized and Prospective Study
Status:
SUSPENDED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
because in a preliminary analysis we would need 1000 patients per group to achieve significative differences in the main end point
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hepatorenal syndrome is a common complication of cirrhotic patients The prognosis of patients with HRS is very poor It have been demonstrated that vasoconstrictors agents Terlipressin plus albumin are effective in the reversal of the treatment However previous studies are pilot studies and they are not able to give information about an improvement in survival This comparative randomized study was delineated to test the efficacy of terlipressin on survival
Detailed Description:
Phase 3
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