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

Primary Purpose

HBV

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Antroquinonol

placebo

About this trial

This is an interventional treatment trial for HBV focused on measuring Antroquinonol, Hocena

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
BMI≦35
HBsAg≧10 IU/mL and HBV DNA≧2000 IU/mL.
AST or ALT≧25 IU and ALT<5xULN
Female subject must use effective methods of contraception.
No abnormal finding of clinical relevance
Written informed consent

Exclusion Criteria:

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
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
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).
Immunodeficiency disorders or severe autoimmune disease
Severe pulmonary disorders or significant cardiac diseases
Gastrointestinal disorder with post-operative condition that could interfere with drug absorption
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
Any malignancy diagnosed within 5 years or evidence of hepatocellular carcinoma (e.g., α fetoprotein > 50ng/mL or radiologic evidence)
Solid organ transplantation
Current drug or alcohol abuse
Pregnancy or lactation
Under hepatitis B antiviral or interferon treatment within 3 months

Sites / Locations

Chung Shan Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Antroquinonol 100 mg PO BID

Antroquinonol 50 mg PO BID

Placebo

Arm Description

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

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

Placebo capsule, 2 capsules placebo, twice a day

Outcomes

Primary Outcome Measures

Percentage

The percentage improvement between baseline and day 85 in quantitative HBsAg.

Secondary Outcome Measures

IU/mL

Sserum hapatitis B virus DNA level

score

The Fibrosis-4 score helps to estimate the amount of scarring in the liver

Unit/L

Glutamic Oxaloacetic Transaminase

Unit /L

Glutamic Pyruvic Transaminase

Full Information

NCT ID

NCT03625102

First Posted

August 5, 2018

Last Updated

September 11, 2023

Sponsor

Golden Biotechnology Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03625102

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

June 16, 2023 (Actual)

Study Completion Date

June 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Golden Biotechnology Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HBV

Keywords

Antroquinonol, Hocena

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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: Antroquinonol 100 mg PO BID Antroquinonol 50 mg PO BID Placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Antroquinonol 100 mg PO BID

Arm Type

Experimental

Arm Description

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

Arm Title

Antroquinonol 50 mg PO BID

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo capsule, 2 capsules placebo, twice a day

Intervention Type

Drug

Intervention Name(s)

Antroquinonol

Other Intervention Name(s)

Hocena

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage

Description

The percentage improvement between baseline and day 85 in quantitative HBsAg.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

IU/mL

Description

Sserum hapatitis B virus DNA level

Time Frame

4 week

Title

score

Description

The Fibrosis-4 score helps to estimate the amount of scarring in the liver

Time Frame

12 week

Title

Unit/L

Description

Glutamic Oxaloacetic Transaminase

Time Frame

4 week

Title

Unit /L

Description

Glutamic Pyruvic Transaminase

Time Frame

4 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 BMI≦35 HBsAg≧10 IU/mL and HBV DNA≧2000 IU/mL. AST or ALT≧25 IU and ALT<5xULN Female subject must use effective methods of contraception. No abnormal finding of clinical relevance Written informed consent Exclusion Criteria: Evidence of hepatic decompensation such as: Coagulopathy defined as prolongation of prothrombin time greater than 3 seconds Total bilirubin of 2 times the upper limit of normal FIB-4 of 3.25 or greater 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 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). Immunodeficiency disorders or severe autoimmune disease Severe pulmonary disorders or significant cardiac diseases Gastrointestinal disorder with post-operative condition that could interfere with drug absorption 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 Any malignancy diagnosed within 5 years or evidence of hepatocellular carcinoma (e.g., α fetoprotein > 50ng/mL or radiologic evidence) Solid organ transplantation Current drug or alcohol abuse Pregnancy or lactation Under hepatitis B antiviral or interferon treatment within 3 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ching-Pin Lin, MD

Organizational Affiliation

Chung Shan Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chung Shan Medical University Hospital

City

Taichung

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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