A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- proportion of participants with HBV DNA < 20 IU/mL
研究概览
简要总结
This study is a multi-center, prospective, real-world study, males and non-pregnant, non-lactating female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
详细描述
This study is a multi-center, prospective, real-world study, aiming to investigate the use of TAF in routine clinical management of chronic hepatitis B patients and evaluate its effectiveness and safety across a heterogeneous population in China. Approximately 500 patients will take part in this study, 10 sites will be included which distribute in China's major cities, thus each site will enroll 50 patients. Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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, consent must be obtained prior to initiation of study procedures
- •Adult males and nonpregnant, nonlactating females
- •Documented evidence of chronic HBV infection previously
排除标准
- •Patents who were TAF experienced
- •Women who are breastfeeding
- •Pregnant females
- •Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
- •Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an imaging study is required)
- •Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, fatty liver disease, cholangitis)
- •Current evidence of Child-Pugh Score C decompensated liver disease,or moderate to severe ascites, Grade III-IV hepatic encephalopathy
- •Abnormal hematological and biochemical parameters, including:
- •Albumin < 2.8 mg/ dL
- •International normalized ratio (INR) > 2.3 X ULN (unless stable on anticoagulant regimen)
- •Total bilirubin > 3 X ULN
- •Patient develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
- •Received solid organ or bone marrow transplant, except patients who underwent liver or kidney transplantation
- •Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible.
- •Individuals receiving ongoing therapy with drugs not to be used with TAF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients
- •Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
- •Use of investigational agents within 3 months of screening, unless allowed by the sponsor
- •Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening
- •Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
- •Inability or unwillingness to provide informed consent or abide by the requirements of the study
- •In addition to the above exclusion criteria, patients who meet any of the contraindications for TAF
研究组 & 干预措施
Tenofovir alafenamide (TAF)
Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with anti-HBV agents.
干预措施: Tenofovir Alafenamide (Drug)
结局指标
主要结局
proportion of participants with HBV DNA < 20 IU/mL
时间窗: 36 months
proportion of participants with HBV DNA \< 20 IU/mL as measured by the COBAS TaqMan HBV Test (Roche Molecular Diagnostics, Pleasanton, CA, USA), with taken at 36 months
次要结局
- The proportion of patients with HBV DNA < 20 IU/mL(24 months)
- The proportion of patients with HBV DNA <300 copies/mL(12 months)
- The proportion of patients with HBV DNA <300 copies/mL IU/mL(36 months)
- Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss(36 months)
- Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe)(36 months)
- Proportion of participants with Normal Alanine Aminotransferase (ALT)(36 months)
- the rate of mother-to-child transmission of HBV(at postpartum 6 months)
- Change from baseline in fibrosis as assessed by Fibroscan®(36 months)
- Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)(36 months)
- Percent Change from baseline in Bone Mineral Density (BMD)(36 months)