The Efficacy and Safety of TAF vs Other NAs in Patients With LVL
The Efficacy and Safety of Tenofovir Alafenamide Fumarate Compared With Other Nucleoside Analogues (Acid) to Treat Patients With Low-level Viremia of HBV
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2020
CompletedStudy Start
First participant enrolled
August 3, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedOctober 29, 2020
October 1, 2020
1.2 years
July 19, 2020
October 28, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 24 week after treatment.
24 week
The changes of glomerular filtration rate
Glomerular filtration rate will be tested to know the changes after treatment
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of bone mineral density in lumbar spine and hip
Bone mineral density in lumbar spine and hip were tested after treatment
0 week, 48 week, 96 week, 144 week.
Secondary Outcomes (12)
Ratio of patients with undetectable hepatitis b virus DNA after treatment
12 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of HBsAg
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of the degree of liver fibrosis
0 week, 48 week, 96 week, 144 week.
Differences in symptoms
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of HBeAg
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
- +7 more secondary outcomes
Study Arms (2)
switch to tenofovir alafenamide fumarate
EXPERIMENTALPatients will switch to tenofovir alafenamide fumarate treatment, 25mg，once a day
Continue with the original regimen
ACTIVE COMPARATORPatients will continue with the original regimen treatment, entecavir, 0.5mg once a day, or tenofovir disoproxil fumarate 300mg once a day
Interventions
Patients would take tenofovir alafenamide fumarate, 25mg，once per day
Patients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day
Eligibility Criteria
You may qualify if:
- HBsAg positive for over half a year;
- Age from 18 to 80 years old;
- Entecavir (0.5mg qd) or Tenofovir disoproxil fumarate (300mg qd) for 48 weeks or more;
- HBV DNA level was between 20IU/ ml-2000 IU /mL (COBAS, Taqman).
You may not qualify if:
- Low-level viremia of HBV caused by non-standard medication;
- serum total bilirubin is more than 2 times the upper limit of normal (ULN), or ALT or AST is more than 5ULN, or serum albumin is less than 30g/L;
- Overlap with HAV, HCV, HDV, HEV or HIV infection;
- Other liver disease: drug liver disease, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease, etc.;
- Decompensated cirrhosis or liver cancer;
- Kidney damage, or autoimmune disease, or other organ failure;
- Combination of Entecavir or Tenofovir disoproxil fumarate ;
- Interferon therapy within half a year;
- Entecavir (0.5mg qd) or Tenofovir disoproxil fumarate;
- Investigator considering inappropriate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuehua Huang, doctorate
Third Affiliated Hospital, Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Laboratory director of hepatology#Deputy director of infection
Study Record Dates
First Submitted
July 19, 2020
First Posted
August 6, 2020
Study Start
August 3, 2020
Primary Completion
October 31, 2021
Study Completion
April 30, 2024
Last Updated
October 29, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share