A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B
A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B
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.
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.
Inclusion Criteria:

 1. 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

 2. BMI≦35

 3. HBsAg≧10 IU/mL and HBV DNA≧2000 IU/mL.

 4. AST or ALT≧25 IU and ALT<5xULN

 5. Female subject must use effective methods of contraception.

 6. No abnormal finding of clinical relevance

 7. Written informed consent

 Exclusion Criteria:

 1. Evidence of hepatic decompensation such as:

 1. Coagulopathy defined as prolongation of prothrombin time greater than 3 seconds

 2. Total bilirubin of 2 times the upper limit of normal

 3. FIB-4 of 3.25 or greater

 2. 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

 3. 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).

 4. Immunodeficiency disorders or severe autoimmune disease

 5. Severe pulmonary disorders or significant cardiac diseases

 6. Gastrointestinal disorder with post-operative condition that could interfere with drug
 absorption

 7. 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

 8. Any malignancy diagnosed within 5 years or evidence of hepatocellular carcinoma (e.g.,
 α fetoprotein > 50ng/mL or radiologic evidence)

 9. Solid organ transplantation

 10. Current drug or alcohol abuse

 11. Pregnancy or lactation

 12. Under hepatitis B antiviral or interferon treatment within 3 months