The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT. (Promote)

Shanghai Jiao Tong University

Status: Active, not recruiting

Conditions: Chronic Hepatitis b; HBV Infection

Treatments: Drug: Tenofovir Amibufenamide（TMF）

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05797714

Promote

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study screening.
2. Male and non-pregnant, non-lactating females, from 18 up to 65 years of age (based on the date of the screening visit). A negative serum pregnancy test at screening is required for female subjects of childbearing potential.
3. Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months).
4. Normal alanine aminotransferase: serum HBV DNA >20 IU/mL and serum ALT level ≤ULN (40 IU/L) during screening.
5. Treatment-naive subjects will be eligible for enrollment.
6. Must be willing and able to comply with all study requirements.

Exclusion criteria

1. Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.

2. Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.

3. Co-infection with HCV virus, HIV, HEV or HDV or combined with autoimmune liver disease, metabolism-related fatty liver disease, drug-induced liver injury;

4. Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging).

5. Any history of, or current evidence of, clinical hepatic decompensation (e.g. ascites encephalopathy or variceal hemorrhage) or liver stiffness over 9kpa measured by TE.

6. Abnormal hematological and biochemical parameters, including:

   Hemoglobin < 10 g/dl Absolute neutrophil count < 0.75 × 10^9/L Platelets ≤ 50 × 10^9/L AST > 10 × ULN Total Bilirubin > 2.5 × ULN Albumin < 3.0 g/dL INR > 1.5 × ULN (unless stable on anticoagulant regimen) eGFR<50mL/min

7. Received solid organ or bone marrow transplant.

8. Malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc).

9. Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.

10. Complicated with uncontrollable cardiovascular and cerebrovascular diseases.

11. Subjects on prohibited concomitant medications. Subjects on prohibited medications, otherwise eligible, will need a wash out period of at least 30 days,Known hypersensitivity to study drugs, metabolites, or formulation excipients.

12. Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.

13. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

TMF treatment group

Experimental group

Description:

TMF 25mg QD, from baseline to 144 weeks

Treatment:

Drug: Tenofovir Amibufenamide（TMF）

Blank control group

No Intervention group

Description:

No antiviral therapy is given. If ALT\>2 ULN (40 IU/L) for HBeAg-positive patients or \> ULN for HBeAg-negative patients during the study period, blank control group can be switched to TMF treatment once a day, 25mg/ time orally until the end of the study.