NCT07606950招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS-5635 Injection in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 540
- 试验地点
- 1
研究概览
简要总结
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks)，NAs-only treatment stage（12 weeks） and the off-treatment follow-up (24 weeks), is up to approximately 100 weeks at maximum for each participant.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •HBeAg negative at screening;
- •On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 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;
- •History of solid organ transplantation or hematopoietic stem cell transplantation;
- •Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
- •Malignant tumors were diagnosed within 5 years 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 QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject 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
HRS-5635 Injection
Experimental
干预措施: HRS-5635 Injection (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
未指定
次要结局
- Percentage of participants who meet the criteria for stopping nucleos(t)ide analogue (NA) therapy(Week 72 and Week 96)
研究者
研究点 (1)
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