A Randomized, Double-Blind, Dosing-Ranging, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage
研究概览
简要总结
Hepatitis B virus infection is a worldwide disease and is still the most common cause of hepatocellular carcinoma (HCC).Existing treatments for hepatitis B infection have various side-effects including renal toxicity and drug resistance or failure.
详细描述
Hepatitis B virus infection is a worldwide disease and is still the most common cause of hepatocellular carcinoma (HCC). Those carriers in China account for 33% of all chronic carriers globally. A big epidemiological study of patients with chronic hepatitis B has revealed that baseline HBV DNA level or cirrhosis is an independent predictor for the occurrence of HCC.
Antroquinonol is a new chemical entity isolated from the mycelium of Antrodia camphorata, which showed interesting anticancer and anti-inflammatory activities.Previous studies have indicated that signaling molecules, such as PI3K, AMPK, and mTOR, participate in Antroquinonol-induced cancer cell death, whereas Nrf2 and NF-kB are involved in the anti-inflammatory effects of Antroquinonol. Moreover, we also found the administration of Antroquinonol also differentially modulated T cell activity and reduced IL-18 production, but enhanced the activation of Nrf2 and, thus, suppressed oxidative stress by animal studies. These results demonstrate the potential applications of Antroquinonol in treating 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HBV infection patients between the ages of 20 and 75 years with serum hepatitis B surface antigen(HBsAg) positivity for more than 6 months
- •HBsAg≧10 IU/mL and HBV DNA≧2000 IU/mL.
- •AST or ALT≧25 IU and ALT<5xULN
- •Female subject must use effective methods of contraception.
- •No abnormal finding of clinical relevance
- •Written informed consent
排除标准
- •Evidence of hepatic decompensation such as:
- •Coagulopathy defined as prolongation of prothrombin time greater than 3 seconds
- •Total bilirubin of 2 times the upper limit of normal
- •FIB-4 of 3.25 or greater
- •Abnormal hematological and biochemical parameters at screening A、 White blood cell count less than 2500 cells/uL B、 Absolute neutrophil count (ANC) less than 1,000 cells/mm3 (less than 750 mm3 for African or African-American subjects) C、 Hemoglobin less than 12 g/dL for males, less than 11 g/dL for females D、 Estimated GFR less than 50 mL/min
- •Suspected or confirmed liver diseases from etiologies other than HBV (such as alcohol, toxin, drug, shock, acute viral hepatitis A or E), co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis delta virus, prior antiviral treatment with NUCs or interferon, and recent immunosuppressive therapy (including chemotherapy and systemic corticosteroid).
- •Immunodeficiency disorders or severe autoimmune disease
- •Severe pulmonary disorders or significant cardiac diseases
- •Gastrointestinal disorder with post-operative condition that could interfere with drug absorption
- •Significant psychiatric illness that in the judgment of the Investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
- •Any malignancy diagnosed within 5 years or evidence of hepatocellular carcinoma (e.g., α fetoprotein > 50ng/mL or radiologic evidence)
- •Solid organ transplantation
- •Current drug or alcohol abuse
- •Pregnancy or lactation
- •Under hepatitis B antiviral or interferon treatment within 3 months
研究组 & 干预措施
Antroquinonol 100 mg PO BID
Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol, twice a day.
干预措施: Antroquinonol (Drug)
Antroquinonol 50 mg PO BID
Antroquinonol (Hocena) 50mg/capsule. 1 capsule antroquinonol and 1 capsule placebo,twice a day.
干预措施: Antroquinonol (Drug)
Antroquinonol 50 mg PO BID
Antroquinonol (Hocena) 50mg/capsule. 1 capsule antroquinonol and 1 capsule placebo,twice a day.
干预措施: placebo (Other)
Placebo
Placebo capsule, 2 capsules placebo, twice a day
干预措施: placebo (Other)
结局指标
主要结局
Percentage
时间窗: 12 weeks
The percentage improvement between baseline and day 85 in quantitative HBsAg.
次要结局
- IU/mL(4 week)
- score(12 week)
- Unit/L(4 week)
- Unit /L(4 week)