A Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B

• Status: Unknown status
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To evaluate the activity of Antroquinonol in patients with chronic hepatitis B

Secondary Objective:

To assess the mechanism and cytokines change of Antroquinonol in patients with chronic hepatitis B

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cheng-Chung Wei
• Collaborator: Golden Biotechnology Corporation
• Treatments: Ubiquinone

Criteria

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. GOT or GPT ≧ 25 IU

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

1. White blood cell count less than 2500 cells/uL

2. Absolute neutrophil count (ANC) less than 1,000 cells/mm3 (less than 750 mm3 for African or African-American subjects)

3. Hemoglobin less than 12 g/dL for males, less than 11 g/dL for females

4. 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