A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B

Golden Biotechnology

Status and phase: Completed; Phase 2

Conditions: HBV

Treatments: Drug: Antroquinonol; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03625102

GHHBV-2-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Antroquinonol 100 mg PO BID

Experimental group

Description:

Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol, twice a day.

Treatment:

Drug: Antroquinonol

Antroquinonol 50 mg PO BID

Experimental group

Description:

Antroquinonol (Hocena) 50mg/capsule. 1 capsule antroquinonol and 1 capsule placebo,twice a day.

Treatment:

Other: placebo

Drug: Antroquinonol

Placebo

Placebo Comparator group

Description:

Placebo capsule, 2 capsules placebo, twice a day

Treatment:

Other: placebo