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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03625102
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Golden Biotechnology Corporation

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.

Condition or disease Intervention/treatment Phase
HBV Drug: Antroquinonol Other: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Dosing-Ranging, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antroquinonol 100 mg PO BID
Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol, twice a day.
Drug: Antroquinonol
Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.
Other Name: Hocena

Experimental: Antroquinonol 50 mg PO BID
Antroquinonol (Hocena) 50mg/capsule. 1 capsule antroquinonol and 1 capsule placebo,twice a day.
Drug: Antroquinonol
Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.
Other Name: Hocena

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

Placebo Comparator: Placebo
Placebo capsule, 2 capsules placebo, twice a day
Other: placebo
The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects




Primary Outcome Measures :
  1. Percentage [ Time Frame: 12 weeks ]
    The percentage improvement between baseline and day 85 in quantitative HBsAg.


Secondary Outcome Measures :
  1. IU/mL [ Time Frame: 4 week ]
    Sserum hapatitis B virus DNA level

  2. score [ Time Frame: 12 week ]
    The Fibrosis-4 score helps to estimate the amount of scarring in the liver

  3. Unit/L [ Time Frame: 4 week ]
    Glutamic Oxaloacetic Transaminase

  4. Unit /L [ Time Frame: 4 week ]
    Glutamic Pyruvic Transaminase



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625102


Contacts
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Contact: Pei-Ni Chen, MD 886-2-28086006 pnchen79@goldenbiotech.com
Contact: CHUN-CHUAN Chang 886-2-28086006 heroman@goldenbiotech.com

Locations
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Taiwan
Chung Shan Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Ching-Pin Lin, MD    886-4-24739595      
Contact: Hsuan-Yi Chen    886-4-24739595    circlerank@gmail.com   
Sponsors and Collaborators
Golden Biotechnology Corporation
Investigators
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Principal Investigator: Ching-Pin Lin, MD Chung Shan Medical University

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Responsible Party: Golden Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT03625102    
Other Study ID Numbers: GHHBV-2-001
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Golden Biotechnology Corporation:
Antroquinonol
Hocena
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic
Ubiquinone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs