Trials / Active Not Recruiting
Active Not RecruitingNCT05797714
The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT.
A Prospective, Randomized, Blank Control, Multicenter Study to Evaluate the Efficacy and Safety of Alanine Aminotransferase（TMF）in the Treatment of Chronic Hepatitis B Patients With Normal Alanine Aminotransferase.
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Ruijin Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, open, blank controlled trial ，in order to evaluate the effectiveness and safety of Amibufenamide（TMF） in the treatment of chronic hepatitis B virus infection patients with normal ALT .
Detailed description
Although the indications for antiviral therapy for patients with chronic hepatitis B have been gradually expanded in different guidelines, antiviral treatment efficacy remains unclear among patients with alanine aminotransferase (ALT) \< 1 upper limits of normal (ULN). This study aimed to evaluate the the effectiveness and safety of TMF for these patients. Tenofovir amibufenamide (TMF; codename: HS-10234), another formulation of tenofovir, shared the same ProTide technology as tenofovir alafenamide, which can provide more efficient intracellular delivery than TDF.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tenofovir Amibufenamide（TMF） | TMF, 25mg QD, from baseline to 240 weeks |
Timeline
- Start date
- 2022-06-08
- Primary completion
- 2024-04-30
- Completion
- 2028-04-30
- First posted
- 2023-04-04
- Last updated
- 2025-11-17
Locations
12 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05797714. Inclusion in this directory is not an endorsement.