Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434753
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-30
Brief Title:
Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease A Multicenter Randomized Double-blind Placebo Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Zinc homeostasis could play a role in advanced chronic liver disease cACLD and its supplementation has been linked with improvement in liver function decrease of hepatic complications and reduction in hepatocellular carcinoma HCC incidence cACLD encompasses a heterogeneous group of patients with a variable risk of clinically significant portal hypertension CSPH and clinical events The ANTICIPATE model is a validated model for stratifying these risks Our aim is to demonstrate that the administration of zinc can reduce the rate and risk of presenting clinical events first decompensation HCC death and liver transplantation This study protocol describes an ongoing phase III national multicentre randomized double-blind clinical trial that will enroll 300 patients to receive either the trial treatment zinc acexamate or placebo An inclusion period of 42 months is planned with a minimal duration of follow up of 2 years Our principal hypothesis is that zinc could modify the natural history of cACLD patients with an overall improvement in prognosis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None