HBVPhase 2NCT03625102
A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B
A Phase 2 study testing Antroquinonol in people with HBV, run by Golden Biotechnology Corporation at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- HBV
- What is being tested?
- Antroquinonol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Feb 2018to 16 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Dosing-Ranging, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B
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.
Read the 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.
- Conditions
- HBV
- Being tested
- Antroquinonol, placebo
- Keywords
- Antroquinonol, Hocena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntroquinonolDrug
Also called Hocena
Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.
placeboOther
The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects
| Study group | Role | What they receive |
|---|---|---|
| Antroquinonol 100 mg PO BID | Experimental | Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol, twice a day. Receives: Drug: Antroquinonol |
| Antroquinonol 50 mg PO BID | Experimental | Antroquinonol (Hocena) 50mg/capsule. 1 capsule antroquinonol and 1 capsule placebo,twice a day. Receives: Drug: Antroquinonol; Other: placebo |
| Placebo | Placebo comparator | Placebo capsule, 2 capsules placebo, twice a day Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative hepatitis B surface antigen (Log qHBsAg)
The primary endpoint is the change from baseline quantitative hepatitis B surface antigen (HBsAg as measured in log10 IU/mL) at Day 85.
Measured: 12 weeks
Secondary outcomes (6)
Serum hapatitis B virus DNA level
Change from baseline serum hapatitis B virus DNA level (HBV DNA as measured in IU/mL) at Day 29, 57 and 85
Measured: 0, 4, 8, 12 week
quantitative hepatitis B surface antigen
Change from baseline quantitative hepatitis B surface antigen at Day 29 and 57
Measured: 0, 4, 8 week
Fibrosis-4 (FIB-4) score
Changes from baseline FIB-4 scale at Day 85; the Fibrosis-4 score helps to estimate the amount of scarring in the liver
Measured: 12 week
Hepatitis B surface antigen loss (HBeAg loss)
Percentage of HBeAg loss at Day 85
Measured: 12 week
Glutamic Oxaloacetic Transaminase (GOT)
Change from baseline GOT at Day 85
Measured: 12 week
Glutamic Pyruvic Transaminase (GPT)
Change from baseline GPT at Day 85
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start12 Feb 2018
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Biotechnology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ching-Pin Lin, MD, Principal investigator, Chung Shan Medical UniversityCheng-Chung Wei, MD, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625102
- Sponsor's protocol ID
- GHHBV-2-001
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2018
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Dosing-Ranging, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT03625102
- Acronym / sponsor ID
- GHHBV-2-001
- Conditions
- HBV
- Keywords
- Antroquinonol, Hocena
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Golden Biotechnology CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Antroquinonol 100 mg PO BID | Experimental | Drug: AntroquinonolAntroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol, twice a day. |
| Antroquinonol 50 mg PO BID | Experimental | Drug: Antroquinonol, Other: placeboAntroquinonol (Hocena) 50mg/capsule. 1 capsule antroquinonol and 1 capsule placebo,twice a day. |
| Placebo | Placebo comparator | Other: placeboPlacebo capsule, 2 capsules placebo, twice a day |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- Evidence of hepatic decompensation such as:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntroquinonolAlso: HocenaAntroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol. | Drug | Antroquinonol 100 mg PO BID, Antroquinonol 50 mg PO BID |
| placeboThe matching placebo will be packaged as Antroquinonol with appearance identical in all aspects | Other | Antroquinonol 50 mg PO BID, Placebo |
Primary outcome
quantitative hepatitis B surface antigen (Log qHBsAg)
Time frame: 12 weeks
The primary endpoint is the change from baseline quantitative hepatitis B surface antigen (HBsAg as measured in log10 IU/mL) at Day 85.
6 secondary outcomes
Serum hapatitis B virus DNA level
Time frame: 0, 4, 8, 12 week
quantitative hepatitis B surface antigen
Time frame: 0, 4, 8 week
Fibrosis-4 (FIB-4) score
Time frame: 12 week
Hepatitis B surface antigen loss (HBeAg loss)
Time frame: 12 week
Glutamic Oxaloacetic Transaminase (GOT)
Time frame: 12 week
Glutamic Pyruvic Transaminase (GPT)
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Pin Lin, MD principal investigator
Chung Shan Medical University
Cheng-Chung Wei, MD principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antroquinonol in people with HBV, run by Golden Biotechnology Corporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantitative hepatitis B surface antigen (Log qHBsAg) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.