Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501224
Status:
UNKNOWN
Last Update Posted:
2020-10-29
First Post:
2020-07-19
Brief Title:
The Efficacy and Safety of TAF vs Other NAs in Patients With LVL
Sponsor:
Third Affiliated Hospital Sun Yat-Sen University
Organization:
Third Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
The Efficacy and Safety of Tenofovir Alafenamide Fumarate Compared With Other Nucleoside Analogues Acid to Treat Patients With Low-level Viremia of HBV
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
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:
Patients with chronic hepatitis B should maximize the inhibition of HBV replication which could reduce the incidence of liver cancer and liver disease-related complications However after 96 weeks of treatment with the first-line drugs entecavir or tenofovir disoproxil fumarate a certain proportion of patients still had low levels of HBV replication Tenofovir alafenamide fumarate is a newly marketed anti-hepatitis B drug that is currently considered to be non-inferior to tenofovir disoproxil fumarate and safer bone and renal effects Therefore this research was put forward to investigate whether tenofovir alafenamide fumarate replacement for hepatitis B had a higher virological response rate and safety in patients with low levels of virus after 48 weeks of treatment with entecavir and tenofovir disoproxil fumarate
Detailed Description:
Patients who meet the inclusion and exclusion criteria will be enrolled into the research The participants will voluntarily choose to enter the experimental group or the control group with full informed consent The control group will continue with the original regimen while the study group will switch to tenofovir alafenamide fumarate antiviral therapy Each group will enroll 100 participants
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?:
None
Is an FDA AA801 Violation?:
None