Trials / Unknown
UnknownNCT05755776
The Efficacy and Safety of Tenofovir Amibufenamide to Treat Low-level Viraemia After Entecavir Treatment
To Evaluate the Efficacy and Safety of Tenofovir Amibufenamide in Chronic Hepatitis B (CHB) Patients With Low-level Viraemia (LLV) After Entecavir Treatment
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 204 (estimated)
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TMF | switch ETV to TMF |
Timeline
- Start date
- 2023-03-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2023-03-06
- Last updated
- 2023-09-21
Locations
13 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05755776. Inclusion in this directory is not an endorsement.