NCT07203118进行中（未招募）2 期
A Phase II/III Seamless Design Clinical Trial of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,444
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events of the Optimal Dosing Regimen as assessed by CTCAE v5.0
研究概览
简要总结
UsingTAF as the control, the nvestigators aim to further explore the efficacy and safety of different dosages of HTS in the treatment of patients with chronic hepatitis B; ultimately, the nvestigators determine the optimal recommended dosage of HTS to provide a basis for Phase III confirmatory clinical research.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •1）Age between 18 to 65 years old (inclusive), regardless of gender. 2) Meets diagnostic criteria for chronic hepatitis B (documented HBsAg positivity or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy histopathology).
- •No prior treatment with any nucleos(t)ide analogue oral antiviral therapy; or, previous treatment with any nucleos(t)ide analogue must have ended at least 6 months prior to baseline.
- •4) Any interferon therapy (both pegylated and non-pegylated) must be completed at least 1 year prior to baseline visit.
- •5) Willing to use effective non-pharmacological contraception during the trial period.
排除标准
- •Hypersensitive to the study drug, its metabolites or any excipient in its formula;
- •With previous or present clinical hepatic decompensation (e.g., ascites, hepatic encephalopathy or varicose vein haemorrhage)
- •Complicated with liver diseases, including chronic alcoholic hepatitis, drug-induced hepatitis, etc.
- •Complicated with HCV, HIV or HDV infections
- •Documented resistance to the antiviral drug (Tenofovir).
- •Any cardiovascular, hematologic,pulmonary or nervous diseases deemed serious by the investigator
研究组 & 干预措施
TAF 25mg
Experimental
干预措施: TAF 25mg (Drug)
HTS 20mg
Experimental
干预措施: HTS 20mg (Drug)
HTS 30mg
Experimental
干预措施: HTS 30mg (Drug)
HTS 40mg
Experimental
干预措施: HTS 40mg (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events of the Optimal Dosing Regimen as assessed by CTCAE v5.0
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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