Ignite Creation Date:
2024-05-05 @ 10:35 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01143246
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2010-06-11
Brief Title:
A Placebo-Controlled Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
A Multi-Center Randomized Placebo-controlled Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin Terlipressin The REVERSE Study
Status:
COMPLETED
Status Verified Date:
2022-11
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:
This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome HRS in participants receiving standard of care albumin therapy
Detailed Description:
Hepatorenal syndrome is a rare syndrome of marked renal dysfunction in patients with cirrhosis decompensated liver disease and portal hypertension Hepatorenal syndrome type 1 is characterized by a rapid progressive renal impairment and has a very poor prognosis with 80 mortality within 3 months At present there are no approved drug therapies for HRS type 1 in the US Australia or Canada The only curative treatment for HRS type 1 and the underlying end-stage cirrhosis is liver transplantation However many patients will not survive long enough to receive a liver transplant and therapy which may provide a bridge to transplantation is badly needed Increased understanding of the pathophysiology of HRS type 1 has demonstrated that vasoconstrictive drug therapy may reverse HRS type 1 Substantial data available from many published clinical investigations in the literature provide compelling evidence suggesting that administration of terlipressin improves renal function in patients with HRS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None