NCT07135349进行中（未招募）2 期
A Multi-center, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of BW-20507 Injection Combined With Pegylated Interferon Alfa in Patients With Chronic Hepatitis B Infection
Shanghai Argo Biopharmaceutical Co., Ltd.17 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2025年9月2日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 209
- 试验地点
- 17
- 主要终点
- 1. The proportion of participants who meet the NUC discontinuation criteria at Week 72 in participants with baseline HBsAg ⩽ 3000 IU/mL and HBeAg-negative.
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 BW-20507 in combination with PEG-IFNα in CHB patients
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must sign ICF and are able to complete the procedures as planned for this study.
- •Males or females aged 18 to 65 (inclusive) when signing informed consent
- •Body mass index (BMI) arranges 18.5 to 32.0 kg/m2 (inclusive)
- •Participants must be diagnosed with chronic hepatitis B infection: HBsAg positivity at least 6 months (need documents)
- •NUC treatment history and screening status of HBV DNA, HBeAg, HBsAg, and ALT must meet the requirements for different cohorts.
- •Males of reproductive potential or females of childbearing potential must agree to utilize reliable contraception, refrain from childbearing plan, and will not donate sperm or eggs during the study
排除标准
- •Clinically significant abnormalities
- •Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) > 9.0 kPa
- •Concomitant clinically significant other liver diseases
- •Previous/current manifestations of hepatic decompensation
- •History of acute or chronic renal insufficiency
- •Significant abnormal ECG at screening
- •Participants with a history of malignancy or who are being evaluated for a possible malignancy
- •Serious mental illness or history
- •Thyroid dysfunction or DM
- •Suspected history of allergy to any component of the study drug
- •Those who are participating in another clinical study, or have not undergone a protocol-specified washout period prior to this study
- •Protocol-specified prohibited therapies usage
- •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
Cohort 1
Experimental
BW-20507 with/without NUC
干预措施: BW-20507 with/without NUC (Drug)
Cohort 2
Experimental
BW-20507 with/without NUC, Peg-IFNa
干预措施: BW-20507 with/without NUC, Peg-IFNa (Drug)
结局指标
主要结局
1. The proportion of participants who meet the NUC discontinuation criteria at Week 72 in participants with baseline HBsAg ⩽ 3000 IU/mL and HBeAg-negative.
时间窗: Week 72
次要结局
- HBsAg changes throughout the study(up to 124 weeks)
研究者
研究点 (17)
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