Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589518
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
To Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Single Center Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 clinical trial aims to confirm the efficacy and safety of Vemlia tablets Tenofovir alafenamide in liver transplant patients with hepatitis B focusing on their effects on renal function
HBV reactivation post-liver transplantation can result in a post-transplant mortality rate of up to 50 within two years making prophylaxis critical Currently a combination therapy of HBIG and nucleotide analogues is commonly used Among the nucleotide analogues NA entecavir ETV and tenofovir disoproxil fumarate TDF are frequently used as first-line therapies However both ETV and TDF have nephrotoxicity requiring caution in patients with chronic kidney disease Specifically 18 of liver transplant patients develop chronic kidney disease due to immunosuppressant use making the appropriate use of antiviral drugs to preserve renal function crucial
TAF has been reported through RCTs to be more effective than TDF in preserving renal function and bone density while showing similar antiviral effects However these studies have been conducted exclusively on general chronic liver disease patients Although multicenter studies have been reported for liver transplant patients they were retrospective and involved a limited number of patients
Therefore the primary objective of this study is to assess the impact of converting to TAF on renal function preservation in liver transplant patients taking antivirals for HBV prophylaxis The secondary objectives are to evaluate the antiviral effect on HBV the impact on lipid profiles and the effectiveness in preserving bone density
HBV reactivation post-liver transplantation can result in a post-transplant mortality rate of up to 50 within two years making prophylaxis critical Currently a combination therapy of HBIG and nucleotide analogues is commonly used Among the nucleotide analogues NA entecavir ETV and tenofovir disoproxil fumarate TDF are frequently used as first-line therapies However both ETV and TDF have nephrotoxicity requiring caution in patients with chronic kidney disease Specifically 18 of liver transplant patients develop chronic kidney disease due to immunosuppressant use making the appropriate use of antiviral drugs to preserve renal function crucial
TAF has been reported through RCTs to be more effective than TDF in preserving renal function and bone density while showing similar antiviral effects However these studies have been conducted exclusively on general chronic liver disease patients Although multicenter studies have been reported for liver transplant patients they were retrospective and involved a limited number of patients
Therefore the primary objective of this study is to assess the impact of converting to TAF on renal function preservation in liver transplant patients taking antivirals for HBV prophylaxis The secondary objectives are to evaluate the antiviral effect on HBV the impact on lipid profiles and the effectiveness in preserving bone density
Detailed Description:
TAF has been reported through RCTs to be more effective than TDF in preserving renal function and bone density while showing similar antiviral effects However these studies have been conducted exclusively on general chronic liver disease patients Although multicenter studies have been reported for liver transplant patients they were retrospective and involved a limited number of patients
Therefore the primary objective of this study is to assess the impact of converting to TAF on renal function preservation in liver transplant patients taking antivirals for HBV prophylaxis The secondary objectives are to evaluate the antiviral effect on HBV the impact on lipid profiles and the effectiveness in preserving bone density
Therefore the primary objective of this study is to assess the impact of converting to TAF on renal function preservation in liver transplant patients taking antivirals for HBV prophylaxis The secondary objectives are to evaluate the antiviral effect on HBV the impact on lipid profiles and the effectiveness in preserving bone density
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