HBV
Conditions
Keywords
Antroquinonol, Hocena
Brief summary
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.
Detailed 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.
Interventions
DRUGAntroquinonol
Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.
OTHERplacebo
The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects
Sponsors
Golden Biotechnology Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a single-center, phase IIa, double blind, and randomized, placebo-controlled trial of Antroquinonol in patients with hepatitis B infection. Subjects with diagnosis of hepatitis B meet inclusion/exclusion criteria will be randomized into 3 groups: 1. Antroquinonol 100 mg PO BID 2. Antroquinonol 50 mg PO BID 3. Placebo
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage | 12 weeks | The percentage improvement between baseline and day 85 in quantitative HBsAg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IU/mL | 4 week | Sserum hapatitis B virus DNA level |
| score | 12 week | The Fibrosis-4 score helps to estimate the amount of scarring in the liver |
| Unit/L | 4 week | Glutamic Oxaloacetic Transaminase |
| Unit /L | 4 week | Glutamic Pyruvic Transaminase |
Countries
Taiwan
Outcome results
None listed