NCT05905458已完成2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase II Study to Evaluate the Efficacy and Safety of HRS9950 Tablets in Chronic Hepatitis B Patients Who Are Virologically Suppressed on Nucleoside or Nucleotide Analogues (NAs)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24
研究概览
简要总结
To evaluate the efficacy and safety of HRS9950 tablets in chronic hepatitis B patients who are virologically suppressed on nucleoside or nucleotide analogues (NAs).
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
- •Meet the body mass index standard among 18.0 to 30 kg/m2;；
- •Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
- •Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
- •On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 12 weeks before randomization;
- •Need to take effective contraceptive measures；
- •Volunteer to sign an informed consent.
排除标准
- •History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;
- •With autoimmune disease;
- •With poorly-controlled diabetes, thyroid disease requiring clinical intervention, clinically significant thyroid dysfunction, neurological or psychiatric disorder, severe lung disease, chronic renal disease or retinopathy;
- •History of solid organ transplantation or hematopoietic stem cell transplantation;
- •Poorly-controlled hypertension, clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
- •Malignant tumors were diagnosed within 5 years prior to randomization；
- •Infection requiring intervention within 4 weeks prior to randomization;
- •Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;
- •Laboratory tests during the screening period were obviously abnormal;
- •Prolonged ECG QTc interval (male > 450ms, female > 470ms) or other clinically significant abnormal results that may pose significant safety risks to subjects during the screening period;
- •History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
- •Participated in clinical study of other drugs (received experimental drugs);
- •Pregnant or nursing women;
- •Allergic to a drug ingredient or component;
- •Other reasons for ineligibility as judged by the investigators.
研究组 & 干预措施
Treatment group A: HRS9950 tablets (Low dose)
Experimental
干预措施: HRS9950 tablets (Drug)
Treatment group B: HRS9950 tablets (High dose)
Experimental
干预措施: HRS9950 tablets (Drug)
Placebo Comparator: Treatment group C
Placebo Comparator
干预措施: HRS9950 placebo tablets (Drug)
结局指标
主要结局
Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24
时间窗: Week 24
次要结局
- Proportion of subjects with serum hepatitis B e-antigen seroconversion(Pre-specified time points up to 48 weeks)
- Proportion of subjects with serum hepatitis B surface antigen seroconversion(Pre-specified time points up to 48 weeks)
- Proportion of subjects with hepatitis B e-antigen loss(Pre-specified time points up to 48 weeks)
- Proportion of subjects with serum hepatitis B surface antigen loss(Pre-specified time points up to 48 weeks)
- Proportion of subjects with drug resistance(Pre-specified time points up to 48 weeks)
- Changes from baseline in mean log10 serum hepatitis B surface antigen levels(Pre-specified time points up to 48 weeks)
- Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen(Pre-specified time points up to 48 weeks)
- Proportion of subjects with virologic breakthrough(Pre-specified time points up to 48 weeks)
研究者
研究点 (1)
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