Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04550481
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2020-09-15
Brief Title:
Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease RELIEF-NAFLD Study
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Role of Lisinopril in Preventing The Progression of Non-Alcoholic Fatty Liver Disease NAFLD Relief-NAFLD
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial investigates how well lisinopril may work in preventing the progression of non-alcoholic fatty liver disease NAFLD NAFLD is a condition where there is an accumulation of fatty cells in the liver NAFLD increases a persons risk of developing liver cancer Liver fibrosis is the common finding of chronic liver diseases leading to reduced liver function Lisinopril is a medication that is commonly used to treat high blood pressure Lisinopril may help to decrease liver fibrosis The purpose of this trial is to find out what effect if any lisinopril has on a patients risk of developing liver cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine if NAFLD patients with advanced fibrosis will demonstrate a change in PRO-C3 a marker of liver fibrosis following 24 weeks of treatment with lisinopril
SECONDARY OBJECTIVES
I Noninvasive measures of fibrosis and steatosis
Ia Change from baseline in PC3X cross-linked multimeric PRO-C3
Ib Change from baseline in steatosis as measured by controlled attenuation parameter CAP or liver ultra-sound attenuation LiSA determined with transient elastography
Ic Change from baseline in liver stiffness as measured with magnetic resonance elastography MRE Id Change from baseline in liver stiffness as measured with transient elastography Ie Changes from baseline in Fibrosis-4 score FIB-4 and NAFLD fibrosis score NFS If Change in inflammatory markers caspase cleaved cytokeratin 18 CK-18 NF-kappaB TGF-beta TNF-alpha IL6 and IL8
OUTLINE
Patients receive lisinopril orally PO once daily QD for 24 weeks in absence of unacceptable toxicity Patients undergo transient elastography during screening and on study Patients also undergo blood sample collection on study and may undergo a proton density fat fraction PDFF magnetic resonance imaging MRI and MRE on study
Patients are followed up at 32 weeks after the start of study medication
I To determine if NAFLD patients with advanced fibrosis will demonstrate a change in PRO-C3 a marker of liver fibrosis following 24 weeks of treatment with lisinopril
SECONDARY OBJECTIVES
I Noninvasive measures of fibrosis and steatosis
Ia Change from baseline in PC3X cross-linked multimeric PRO-C3
Ib Change from baseline in steatosis as measured by controlled attenuation parameter CAP or liver ultra-sound attenuation LiSA determined with transient elastography
Ic Change from baseline in liver stiffness as measured with magnetic resonance elastography MRE Id Change from baseline in liver stiffness as measured with transient elastography Ie Changes from baseline in Fibrosis-4 score FIB-4 and NAFLD fibrosis score NFS If Change in inflammatory markers caspase cleaved cytokeratin 18 CK-18 NF-kappaB TGF-beta TNF-alpha IL6 and IL8
OUTLINE
Patients receive lisinopril orally PO once daily QD for 24 weeks in absence of unacceptable toxicity Patients undergo transient elastography during screening and on study Patients also undergo blood sample collection on study and may undergo a proton density fat fraction PDFF magnetic resonance imaging MRI and MRE on study
Patients are followed up at 32 weeks after the start of study medication
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG1CA242643 | NIH | DCP | httpsreporternihgovquickSearchUG1CA242643 |
| NCI-2020-06905 | REGISTRY | None | None |
| NCI20-01-03 | OTHER | None | None |
| NWU20-01-03 | OTHER | None | None |
| P30CA060553 | NIH | None | None |