NCT05797714进行中（未招募）不适用
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.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
- •Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
- •Co-infection with HCV virus, HIV, HEV or HDV or combined with autoimmune liver disease, metabolism-related fatty liver disease, drug-induced liver injury;
- •Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging).
- •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.
- •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
- •Received solid organ or bone marrow transplant.
- •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).
- •Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
- •Complicated with uncontrollable cardiovascular and cerebrovascular diseases.
- •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.
- •Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
- •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.
研究组 & 干预措施
TMF treatment group
Experimental
TMF 25mg QD, from baseline to 240 weeks
干预措施: Tenofovir Amibufenamide（TMF） (Drug)
结局指标
主要结局
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL
时间窗: Week 48
The primary efficacy endpoint was the proportion of patients with HBV DNA \< 20 IU/mL at week 48
次要结局
- Evaluation the change from Baseline in HBV DNA(Week 48，Week 96，Week 144，week 240)
- Evaluation the proportion of Patients Achieving Hepatitis B Surface Antigen (HBsAg) Loss(Week 48，Week 96，Week 144，Week 240)
- Evaluation the proportion of Patients Achieving HBsAg Seroconversion(Week 48，Week 96, Week 144, Week 240)
- Evaluation the proportion of Patients Achieving HBeAg Seroconversion(Week 48，Week 96，Week 144, Week 240)
- Evaluation the proportion of Patients Achieving HBeAg Loss(Week 48，Week 96，Week 144 ，Week 240)
- Evaluation the change from Baseline in HBsAg(Week 48，Week 96，Week 144，Week 240)
- Evaluation the percentage of Participants with resistance(Week 48，Week 96，Week 144，Week 240)
- Evaluation the change from Baseline in liver fibrosis(Week 48，Week 96，Week 144，Week 240)
- Evaluation the proportion of Patients with get hepatitis acute attack（ALT >5 ULN (40 IU/L)）(Week 48，Week 96，Week 144，Week 240)
- Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL(Week 96，Week 144，Week 240)
- Evaluation the change from Baseline in Bone biomarker（β-CTX and P1NP）(Week 48，Week 96，Week 144，Week 240)
- Evaluation the change from Baseline in sCR(Week 48，Week 96，Week 144，Week 240)
- AE ,SAE(Week 48，Week 96，Week 144，Week 240)
- The proportion of subjects with liver-related events(Week 48，96，144，192，240)
研究者
研究点 (12)
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