NCT04501224

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis b
• Cirrhosis Due to Hepatitis B

Interventions

Type	Name	Description
DRUG	Tenofovir alafenamide fumarate	Patients would take tenofovir alafenamide fumarate, 25mg，once per day
DRUG	Entecavir or Tenofovir disoproxil fumarate	Patients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day

Timeline

• Start date: 2020-08-03
• Primary completion: 2021-10-31
• Completion: 2024-04-30
• First posted: 2020-08-06
• Last updated: 2020-10-29

Locations

1 site across 1 country: China