NCT07307586招募中3 期
A Small Prospective Clinical Study on Azvudine Tablets for Treating Chronic Hepatitis B.
Zhigang Ren1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年9月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Follow-up at 12 months
研究概览
简要总结
Through regular monitoring of viral load, liver function and immune cell activity, the long-term efficacy of Adefovir in controlling HBV is precisely evaluated. By employing a dual mechanism of "antiviral action plus immune activation", it offers a novel therapeutic option for achieving clinical cure in chronic hepatitis B.
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
- Single (Participant)
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
- •All subjects must meet the following criteria to be eligible for inclusion in the trial:
- •Meet the diagnostic criteria for viral hepatitis as outlined in the Chinese Medical Association's Hepatology Branch Guidelines for the Prevention and Treatment of Chronic Hepatitis B, with patients demonstrating sustained positivity for hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) for at least six months;
- •HBV DNA load > 20,000 copies/mL and HBsAg < 1,500 IU/mL;
- •Serum alanine aminotransferase (ALT) > 2 times the upper limit of normal;
- •No prior antiviral therapy prior to hospital admission.
排除标准
- •All subjects meeting any of the following criteria shall be excluded from this study:
- •Individuals co-infected with other hepatotropic viruses, such as hepatitis A, C, D, or E viruses, or HIV;
- •Patients with concomitant liver metabolic disorders, cirrhosis, autoimmune-related diseases, or other chronic conditions;
- •Pregnant or breastfeeding women, or those planning pregnancy within one year;
- •Patients who have received or are currently undergoing antineoplastic therapy;
- •History of alcohol or substance abuse;
- •Patients currently taking therapeutic medications or health supplements;
- •Patients who participated in other clinical trials within 30 days prior to enrolment;
- •Patients with allergic constitutions or hypersensitivity to any drug or component used in this study;
- •Patients with gastrointestinal disorders that may impair drug absorption.
研究组 & 干预措施
TAF Group
Active Comparator
CHB patients with TAF treatment
干预措施: TAF (Drug)
Azvudine Group
Experimental
CHB patients with Azvudine treatment
干预措施: AZVUDINE (Drug)
IFN α-2a Group
Active Comparator
CHB patients with IFN α-2a treatment
干预措施: IFNα-2a (Drug)
结局指标
主要结局
Follow-up at 12 months
时间窗: 12 month
Taking the medication orally for 12 months.
次要结局
- Adverse events(Up to 30 days (form the date of confirmed CHB))
研究者
Zhigang Ren
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Zhengzhou University
研究点 (1)
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