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

HBV Clinical Trial

Official title:

A Randomized, Double-Blind, Dosing-Ranging, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625102
• Other study ID #: GHHBV-2-001
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2018
• Est. completion date: June 16, 2023

Study information

• Verified date: September 2023
• Source: Golden Biotechnology Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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., a 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

Related Conditions & MeSH terms

• HBV
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Antroquinonol
Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.

Other:
• placebo
The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Golden Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage	The percentage improvement between baseline and day 85 in quantitative HBsAg.	12 weeks
Secondary	IU/mL	Sserum hapatitis B virus DNA level	4 week
Secondary	score	The Fibrosis-4 score helps to estimate the amount of scarring in the liver	12 week
Secondary	Unit/L	Glutamic Oxaloacetic Transaminase	4 week
Secondary	Unit /L	Glutamic Pyruvic Transaminase	4 week