Tenofovir Amibufenamide(TMF): TMF, 25mg QD, from baseline to 240 weeks
Study 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 .
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL — Week 48 The primary efficacy endpoint was the proportion of patients with HBV DNA \< 20 IU/mL at week 48
Trial sites (12)
Facility
City
Region
Status
The Second Xiangya Hospital, Central South University
Changsha
Hunan
Beijing You'An Hospital, Capital Medical University
Beijing
China
People's Hospital of Dongyang City
Dongyang
China
Fuyang Second People's Hospital
Fuyang
China
The First People's Hospital of Xiaoshan District, Hangzhou, Zhejiang Province
Hangzhou
China
LiShui People's Hospital of Zhejiang Province
Lishui
China
The First Affiliated Hospital of Nanchang University
Nanchang
China
Jiangsu Province Hospital
Nanjin
China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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