NCT03099278Unknown2 期
Ezetimibe for Patients With Chronic Hepatitis D
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- • Decline of HDV RNA quantitative measurements of >1 logs from baseline
研究概览
简要总结
Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry that include two hydrophobes and one hydrogen bond acceptor. Therapy with Ezetimibe may lead to decline in hepatitis D virus levels. The aim of the study is to evaluate the utility of Ezetimibe in patients with chronic HDV infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment experienced patients; non-responders of relapsers of pegylated interferon therapy
- •Age 18 years or above
- •Presence of anti-HDV in serum
- •Presence of quantifiable HDV RNA in serum
- •Elevated ALT > ULN
排除标准
- •Decompensated liver disease
- •Patients with ALT levels greater than 10 times ULN (400 U/L)
- •Pregnancy or inability to practice adequate contraception.
- •Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR<50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease.
- •Systemic immunosuppressive therapy
- •Evidence of another form of liver disease in addition to viral hepatitis
- •Active substance abuse, such as alcohol or injection drugs
- •Hepatocellular carcinoma
- •Concurrent hepatitis C infection or HIV coinfection
- •Diagnosis of malignancy in the five years
- •Concurrent usage of statins
- •Concurrent use of any other drug known to inhibit NTCP
- •Inability to understand or sign informed consent
- •Any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study
研究组 & 干预措施
Ezetimibe
Experimental
干预措施: Ezetimibe (Drug)
结局指标
主要结局
• Decline of HDV RNA quantitative measurements of >1 logs from baseline
时间窗: 12 weeks of therapy
次要结局
未报告次要终点
研究者
研究点 (1)
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