NCT05355467已完成4 期
Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum
Mylan (Taiwan) Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of the rates of virological recurrence of HBV
研究概览
简要总结
This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged more than 20 years old;
- •CHB patients who have been treated with Viread® for more than 1 year;
- •Serum HBV DNA level is undetectable (not detected or <20 IU/mL) at screening;
- •Informed consent must be obtained before the commencement of any screening procedures or study drugs
排除标准
- •Patients with active HCC or other types of malignancy;
- •Patients with impaired renal function (defined as eGFR ≦ 30 mL/min/1.73m2);
- •Patients with hepatitis A (HAV), hepatitis C (HCV), hepatitis D (HDV) or human immunodeficiency virus (HIV) coinfection;
- •Patients with alcohol dependence or addiction;
- •Patients with autoimmune hepatitis;
- •Patients with primary biliary cholangitis (PBC);
- •Pregnancy, planning on getting pregnant, or breast-feeding;
- •History of allergy, hypersensitivity, intolerance, or experiencing severe adverse reactions to tenofovir or any ingredient of the study drug;
- •Not suitable for participating in this trial at the investigator's discretion.
- •Historical Control Group
- •Eligible individuals will be obtained from the TCVGH historical database based on matching (1:1) in terms of age (±5 years) and gender. To be eligible for the study, subjects must meet all of the following criteria:
- •Male or female aged more than 20 years old;
- •CHB patients who had been treated with Viread® for more than 1 year;
- •Patients who had discontinued Viread® therapy for at least 24 weeks during the period from January 2014 to December 2021 and had undetectable HBV DNA (not detected or <20 IU/mL) in serum at the time of discontinuation;
- •Patients who have the data of HBV DNA level 24 weeks after the time of discontinuation, with a time window of +4 weeks is allowed;
- •The informed consent requirement will be waived based on the approval of IRB.
研究组 & 干预措施
Ricovir® group
Experimental
干预措施: Tenofovir disoproxil fumarate (Drug)
Historical Control Group
Other
干预措施: Historical Data (Other)
结局指标
主要结局
Assessment of the rates of virological recurrence of HBV
时间窗: Week 24
To assess the rates of virological recurrence of HBV at Week 24 with Ricovir® treatment.
次要结局
- Comparison of the HBV DNA levels between Ricovir® group and historical control group(Week 24)
- Comparison of the rates of virological recurrence of HBV between Ricovir® group and historical control group.(Week 24)
- Monitoring of Safety profile for subjects in Ricovir® group(Up to 24 weeks)
研究者
研究点 (1)
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