Pure Global AI
NCT05755776Not yet recruiting

Efficacy and Safety of TMF in the Treatment of CHB Patients With Low-level Viraemia

A Prospective, Observational, Parallel Control, Multicenter Study to Evaluate the Efficacy and Safety of Tenofovir Amibufenamide in the Treatment of Chronic Hepatitis B Patients With Low-level Viraemia (Power Study)
The Second Affiliated Hospital of Chongqing Medical UniversityClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Hepatitis B
Drug/Device/Intervention
TMF
Study type
Observational
Intervention type
drug
Sponsor & location
Primary sponsor
The Second Affiliated Hospital of Chongqing Medical University
Location
Chongqing,Chongqing,Guangxi,Guiyang,Jilin,Kunming,Kunming,Nanjing,Ningbo,Shanghai,Shanghai,Shenyang,Shijiazhuang,Taicang,Zibo, China
Timeline & enrollment
Phase
N/A
Start date
Mar 01, 2023
End date
Dec 01, 2024
Enrollment
204 participants
Primary outcome

The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 48.

Summary

The goal of this observational study is to explore the efficacy and safety of Tenofovir
 Amibufenamide (TMF) in Entecavir (ETV) treated chronic hepatitis B patients with low-level
 viraemia. The main question it aims to answer is:
 
 - The efficacy and safety of TMF in chronic hepatitis B patients with low-level viraemia.
 
 - What is the appropriate treatment for ETV treated chronic hepatitis B patients with
 low-level viraemia.
 
 Participants will choose to maintain their original regimen (ETV) or switch to TMF After
 being fully informed of the benefits and risks of treatment.
 
 Researchers will compare ETV and TMF to see if there is a difference in the efficacy of the
 two drugs in chronic hepatitis B patients with low-level viraemia.

ICD-10 classifications
Acute hepatitis BChronic viral hepatitis B without delta-agentAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agent : other and unspecified phaseChronic viral hepatitis B without delta-agent : immune-tolerant phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05755776
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05755776 through Pure Global AI's free database. This phase not specified trial is sponsored by The Second Affiliated Hospital of Chongqing Medical University and is currently Not yet recruiting. The study focuses on Chronic Hepatitis B. Target enrollment is 204 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.