An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- change from baseline HBV-DNA at 1/3/6/12month
研究概览
简要总结
In June 2021, Chinese Food and Drug Administration approved the launch of the self-developed new drug Tenofovir Amibufenamide(TMF). TMF is a new second generation of tenofovir(TFV) and its effect on blood lipids is unclear. Our study aims to figure out the effect of TMF on serum lipid level in the process of antiviral therapy for chronic hepatitis B patients.
详细描述
In June 2021, Chinese Food and Drug Administration approved the launch of the self-developed new drug Tenofovir Amibufenamide(TMF). TMF is the phosphoramidite precursor of Tenofovir, belonging to the nucleoside reverse transcriptase and owning higher cell membrane penetration rate, which make it easier to enter hepatocytes and achieve liver-targeted therapy. Meanwhile, TMF can effectively improve drug stability in plasma and reduce systemic tenofovir(TFV) exposure, and make long-term treatment safer.
Previous studies have shown that tenofovir disoproxil (TDF), the first generation of TFV, had the effect of lowering blood lipids. While patients who switched to tenofovir alafenamide (TAF), the second generation of TFV, had elevated blood lipids. TMF is a new second generation of TFV and its effect on blood lipids is unclear. Our study aims to figure out the effect of TMF on serum lipid level in the process of antiviral therapy for chronic hepatitis B patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old;
- •Chronic hepatitis B patients who meet the CHB diagnostic criteria of "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (Chinese 2019 version)";
- •HBV-DNA can be detected (≥20IU/mL);
- •With or without liver cirrhosis caused by hepatitis B;
- •The treatment plan is TMF antiviral therapy, and no other antiviral drugs are used for at least 1 year before;
- •The clinical data are relatively complete, and the follow-up time reaches 24 weeks (6 months).
排除标准
- •Patients with primary liver cancer or liver metastases;
- •Combined with hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus and human immunodeficiency virus infection;
- •Combined with alcoholic liver disease, drug-induced liver disease, autoimmune liver disease and liver disease caused by other factors;
- •History of treatment of dysglycemia and dyslipidemia;
- •Patients with lactose intolerance;
- •Pregnant women and lactating women;
- •Patients with other serious systemic diseases.
研究组 & 干预措施
group B1
baseline blood lipid is elevated and treat with lipid-lowering drugs
干预措施: lipid lowering drugs (e.g. Atorvastatin and amlodipine.) (Drug)
group B1
baseline blood lipid is elevated and treat with lipid-lowering drugs
干预措施: oral Tenofovir Amibufenamide 25mg each day (Drug)
group A
normal blood lipid level at baseline
干预措施: oral Tenofovir Amibufenamide 25mg each day (Drug)
group B2
baseline blood lipid is elevated and without lipid-lowering drugs treatment
干预措施: oral Tenofovir Amibufenamide 25mg each day (Drug)
结局指标
主要结局
change from baseline HBV-DNA at 1/3/6/12month
时间窗: baseline, follow up of 1,3,6,12month
test virological response rate
change from baseline level of blood lipid at 1/3/6/12month
时间窗: baseline, follow up of 1,3,6,12month
test blood lipid level
次要结局
- change from baseline serum calcium at 6/12month(baseline, follow up of 6,12month)
- change from baseline serum phosphorus at 6/12month(baseline, follow up of 6,12month)
研究者
Jin Ye
professor, chief doctor
Wuhan Union Hospital, China