NCT07069569招募中2 期
A Randomized, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Combination With Hepatitis B Vaccine or Pegylated Interferon α-2b (Peg-IFN) in Participants With HBeAg-Negative Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogue (NAs)
Ausper Biopharma Co., Ltd.11 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年6月8日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.
研究概览
简要总结
This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with 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
- 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
- •Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
- •Aged between 18 and 65 years at the time of signing the ICF;
- •Body mass index (BMI) within the range of 18-30 kg/ m2;
- •HBeAg negative at screening;
- •HBsAg or HBV DNA positive for at least 6 months;
- •Continue antiviral therapy with a single nucleoside (t) ide analogue for more than 6 months prior to screening;
- •Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
- •Effective contraception as required.
排除标准
- •Participants who are not eligible for treatment with Peg-IFN/recombinant hepatitis B vaccine;
- •Clinically significant abnormalities other than a history of chronic HBV infection;
- •Concomitant clinically significant other liver diseases;
- •Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to screening;
- •HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive;
- •Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) > 9.0 kPa;
- •Previous/current manifestations of hepatic decompensation;
- •Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein concentration (AFP) ≥ 20 ng/mL at screening;
- •Obviously abnormal laboratory test results;
- •History of vasculitis or presence of signs, symptoms, or laboratory tests of underlying vasculitis, and previous/current other diseases that may be related to vasculitic conditions;
- •QT interval corrected for heart rate (Fridericia method) abnormal;
- •History of extrahepatic disease possibly related to HBV immune status;
- •Participants with a history of malignancy within the past 5 years or who are being evaluated for a possible malignancy;
- •Serious mental illness or history of serious mental illness prior to screening;
- •Suspected history of allergy to any component of the study drug, or allergic constitution;
- •Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;
- •Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
- •Current use or use of any immunosuppressive medication within 3 months prior to screening, with the exception of short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose;Or a history of vaccination within 6 months prior to screening or a live vaccination plan during the trial;
- •Participants requiring regular long-term administration of anticoagulants or antiplatelet drugs;
- •Thyroid dysfunction;
- •Patients with uncontrolled epilepsy and other progressive neurological disorders;
- •Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug;
- •Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.
研究组 & 干预措施
AHB-137 and Hepatitis B vaccine
Experimental
干预措施: AHB-137 (Drug)
AHB-137 (16 weeks) and Peg-IFN
Experimental
干预措施: Peg-IFN (Drug)
AHB-137 (24 weeks) and Peg-IFN
Experimental
干预措施: AHB-137 (Drug)
AHB-137 (24 weeks) and Peg-IFN
Experimental
干预措施: Peg-IFN (Drug)
AHB-137 and Hepatitis B vaccine
Experimental
干预措施: Hepatitis B Vaccine (Drug)
AHB-137 (16 weeks) and Peg-IFN
Experimental
干预措施: AHB-137 (Drug)
AHB-137 (24 weeks) and Peg-IFN(24 weeks)
Experimental
R3 group
干预措施: Peg-IFN (Drug)
AHB-137 (24 weeks) and Peg-IFN(24 weeks)
Experimental
R3 group
干预措施: AHB-137 (Drug)
AHB-137
Experimental
干预措施: AHB-137 (Drug)
结局指标
主要结局
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.
时间窗: up to 72 weeks
次要结局
- Safety: Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.(Up to 72 weeks)
- Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.(Up to 72 weeks)
- Safety: Monitoring the score changes of Columbia Suicide Severity Scale (CSSRS) .(Up to 72 weeks.)
- Safety: Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.(Up to 72 weeks)
- Safety: Monitoring the score changes of Self-Rating Depression Scale (SDS).(Up to 72 weeks.)
- Discontinue all treatment for CHB for 24 weeks with HBV DNA<LLOQ and HBsAg<10IU/mL.(Up to 72 weeks)
- Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ .(Up to 72 weeks)
- Detection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.(Up to 72 weeks)
- Proportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period.(Up to 48 weeks)
- Relapse rate after discontinuation of NAs therapy.(Up to 72 weeks)
- Change from baseline in alanine aminotransferase (ALT) values and time to normalization of values.(Up to 72 weeks)
- Relapse time after discontinuation of NAs therapy.(Up to 72 weeks)
- Plasma concentrations of AHB-137.(Up to 48 weeks)
- Serum concentrations of Peg-IFN.(Up to 48 weeks.)
- Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).(Up to 72 weeks)
- Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ .(Up to 72 weeks)
- Detection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.(Up to 72 weeks)
- Proportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period.(Up to 48 weeks)
- Relapse rate after discontinuation of NAs therapy.(Up to 72 weeks)
- Change from baseline in alanine aminotransferase (ALT) values and time to normalization of values.(Up to 72 weeks)
- Relapse time after discontinuation of NAs therapy.(Up to 72 weeks)
- Plasma concentrations of AHB-137.(Up to 48 weeks)
- Serum concentrations of Peg-IFN.(Up to 48 weeks.)
- Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).(Up to 72 weeks)
- Safety: Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.(Up to 72 weeks)
- Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.(Up to 72 weeks)
- Safety: Monitoring the score changes of Columbia Suicide Severity Scale (CSSRS) .(Up to 72 weeks.)
- Safety: Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.(Up to 72 weeks)
- Safety: Monitoring the score changes of Self-Rating Depression Scale (SDS).(Up to 72 weeks.)
研究者
研究点 (11)
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