Status:
UNKNOWN
The Efficacy and Safety of TAF vs Other NAs in Patients With LVL
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Chronic Hepatitis b
Cirrhosis Due to Hepatitis B
Eligibility:
All Genders
18-80 years
Phase:
NA
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 o...
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 infor...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04501224
Start Date
August 3 2020
End Date
April 30 2024
Last Update
October 29 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630