Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 主要终点
- Change in HDV RNA quantitative measurements of >2 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.
The aim of the study io evaluate the utility of Ezetimibe in combination with pegylated interferon in patients with chronic HDV infection.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
研究组 & 干预措施
Pegylated interferon
Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks
干预措施: Pegylated interferon alfa (Drug)
Pegylated interferon with ezetimibe
Pegylated interferon alfa 180 micro-gram subcutaneous weekly for 24 weeks and Ezetimibe 10 mg orally for 24 weeks
干预措施: Pegylated interferon alfa (Drug)
Pegylated interferon with ezetimibe
Pegylated interferon alfa 180 micro-gram subcutaneous weekly for 24 weeks and Ezetimibe 10 mg orally for 24 weeks
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Change in HDV RNA quantitative measurements of >2 logs from baseline
时间窗: 24 weeks of therapy
次要结局
未报告次要终点
研究者
Zaigham Abbas
Consultant Gastroenterologist
Aga Khan University