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Trial record 4 of 9 for:    antroquinonol

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

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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

Tracking Information
First Submitted Date  ICMJE August 5, 2018
First Posted Date  ICMJE August 10, 2018
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
Percentage [ Time Frame: 12 weeks ]
The percentage improvement between baseline and day 85 in quantitative HBsAg.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • IU/mL [ Time Frame: 4 week ]
    Sserum hapatitis B virus DNA level
  • score [ Time Frame: 12 week ]
    The Fibrosis-4 score helps to estimate the amount of scarring in the liver
  • Unit/L [ Time Frame: 4 week ]
    Glutamic Oxaloacetic Transaminase
  • Unit /L [ Time Frame: 4 week ]
    Glutamic Pyruvic Transaminase
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B
Official Title  ICMJE A Randomized, Double-Blind, Dosing-Ranging, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE HBV
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Antroquinonol 100 mg PO BID
    Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol, twice a day.
    Intervention: Drug: Antroquinonol
  • Experimental: Antroquinonol 50 mg PO BID
    Antroquinonol (Hocena) 50mg/capsule. 1 capsule antroquinonol and 1 capsule placebo,twice a day.
    Interventions:
    • Drug: Antroquinonol
    • Other: placebo
  • Placebo Comparator: Placebo
    Placebo capsule, 2 capsules placebo, twice a day
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pei-Ni Chen, MD 886-2-28086006 pnchen79@goldenbiotech.com
Contact: CHUN-CHUAN Chang 886-2-28086006 heroman@goldenbiotech.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03625102
Other Study ID Numbers  ICMJE GHHBV-2-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Golden Biotechnology Corporation
Study Sponsor  ICMJE Golden Biotechnology Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ching-Pin Lin, MD Chung Shan Medical University
PRS Account Golden Biotechnology Corporation
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP