The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT.
- Conditions
- HBV InfectionChronic Hepatitis b
- Interventions
- Registration Number
- NCT05797714
- Lead Sponsor
- Ruijin Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study screening.
- 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.
- Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months).
- Normal alanine aminotransferase: serum HBV DNA >20 IU/mL and serum ALT level ≤ULN (40 IU/L) during screening.
- Treatment-naive subjects will be eligible for enrollment.
- Must be willing and able to comply with all study requirements.
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Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
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Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
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Co-infection with HCV virus, HIV, HEV or HDV or combined with autoimmune liver disease, metabolism-related fatty liver disease, drug-induced liver injury;
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Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging).
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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.
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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
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Received solid organ or bone marrow transplant.
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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).
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Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
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Complicated with uncontrollable cardiovascular and cerebrovascular diseases.
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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.
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Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TMF treatment group Tenofovir Amibufenamide（TMF） TMF 25mg QD, from baseline to 144 weeks
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Evaluation the change from Baseline in liver fibrosis Week 48，Week 96，Week 144 Change from baseline in liver fibrosis
Evaluation the change from Baseline in sCR Week 48，Week 96，Week 144 Evaluation the change from Baseline in HBV DNA Week 48，Week 96，Week 144 Change from baseline in HBV DNA
Evaluation the proportion of Patients Achieving HBeAg Loss Week 48，Week 96，Week 144 Proportion of patients Achieving HBeAg Loss
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL Week 96，Week 144 Evaluation the proportion of Patients Achieving Hepatitis B Surface Antigen (HBsAg) Loss Week 48，Week 96，Week 144 Proportion of patients achieving Hepatitis B surface antigen (HBsAg) loss
Evaluation the proportion of Patients with get hepatitis acute attack（ALT >5 ULN (40 IU/L)） Week 48，Week 96，Week 144 Proportion of patients with get hepatitis acute attack（ALT \>5 ULN (40 IU/L)）
AE ,SAE Week 48，Week 96，Week 144 Evaluation the proportion of Patients Achieving HBsAg Seroconversion Week 48，Week 96，Week 144 Proportion of patients achieving HBsAg seroconversion
Evaluation the proportion of Patients Achieving HBeAg Seroconversion Week 48，Week 96，Week 144 Proportion of patients achieving HBeAg seroconversion
Evaluation the change from Baseline in HBsAg Week 48，Week 96，Week 144 Change from baseline in HBsAg
Evaluation the percentage of Participants with resistance Week 48，Week 96，Week 144 Percentage of participants with resistance
Evaluation the change from Baseline in Bone biomarker（β-CTX and P1NP） Week 48，Week 96，Week 144
Trial Locations
- Locations (12)
People's Hospital of Dongyang City
🇨🇳Dongyang, China
The Second Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China
Beijing You'An Hospital, Capital Medical University
🇨🇳Beijing, China
Fuyang Second People's Hospital
🇨🇳Fuyang, 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.
🇨🇳Shanghai, China
Shanghai East Hospital
🇨🇳Shanghai, China
The First People's Hospital of Xiaoshan District, Hangzhou, Zhejiang Province
🇨🇳Hangzhou, China
The Fifth People's Hospital of Suzhou
🇨🇳Suzhou, China
The Fifth People's Hospital of Wuxi
🇨🇳Wuxi, China