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A Randomized, Placebo-controlled 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: NCT04112147
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
Golden Biotechnology Corporation
Information provided by (Responsible Party):
Cheng-Chung Wei, Chung Shan Medical University

Tracking Information
First Submitted Date  ICMJE October 1, 2019
First Posted Date  ICMJE October 2, 2019
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE August 10, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
quantitative hepatitis B surface antigen (Log qHBsAg) [ Time Frame: Week 0 and Week 12 ]
The primary endpoint is the change from baseline in quantitative hepatitis B surface antigen (Log qHBsAg) at Week 12.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
  • serum hapatitis B virus DNA level [ Time Frame: Week 0, Week 4, Week 8 and Week 12 ]
    Change from baseline serum hapatitis B virus DNA level(HBV DNA as measured in IU/mL) at Week 4, Week 8 and Week 12
  • hepatitis B surface antigen [ Time Frame: Week 0, Week 4 and Week 8 ]
    Change from baseline quantitative hepatitis B surface antigen at Week 4 and Week 8
  • Fibrosis-4(FIB-4) scale [ Time Frame: Week 0 and Week 12 ]
    Changes from baseline FIB-4 scale at Week 12
  • Hepatitis B surface antigen loss (HBeAg loss) [ Time Frame: Week 12 ]
    Percentage of HBeAg loss at Week 12
  • glutamate oxaloacetate transaminase (GOT) [ Time Frame: Week 0 and Week 12 ]
    Change from baseline GOT at Week 12
  • Glutamic Pyruvic Transaminase (GPT) [ Time Frame: Week 0 and Week 12 ]
    Change from baseline GPT at Week 12
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, Placebo-controlled 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

Primary Objective:

To evaluate the activity of Antroquinonol in patients with chronic hepatitis B

Secondary Objective:

To assess the mechanism and cytokines change of Antroquinonol in patients with chronic hepatitis B

Detailed Description

This is a Phase II, three-arms, double-blind, dosing-ranging, placebo-controlled trial evaluating the efficacy of Antroquinonol in patients with chronic hepatitis B. The study is conducted in compliance with the guidelines for Good Clinical Practice and the Declaration of Helsinki. Approval is obtained from the local ethics committee or institutional review board at each study center. All the patients provided written informed consent.

60 patients totally (20 patients per arm) with chronic hepatitis B will receive Antroquinonol or placebo. A patient will have received at one dose of Antroquinonol or placebo. Enrollment will continue until the target number of evaluable patients has been enrolled.

Written informed consent must be obtained from all patients before initiating Screening. The Screening period will be up to 14 days in duration (Days -14 to -1). Following completion of all Screening assessments and confirmation of eligibility criteria, patients will receive Antroquinonol 100mg, 200mg or placebo per day on Day 1 for 12 weeks or until documented evidence of virus DNA > 10 x [minimum], unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first. The time of study drug administration should be recorded in the patient diary.

Patients will attend study visits on Days 1, 29, 57 and 85. The following procedures will be performed according to the schedule of assessments: physical examination, vital signs, clinical laboratory tests, adverse events (AEs), concomitant medication and patient compliance.

The primary endpoint is the change from baseline in quantitative hepatitis B surface antigen (Log qHBsAg) at Day 85.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis B
Intervention  ICMJE
  • Drug: Antroquinonol capsule 100mg
    Patients will receive 12-week of 50mg BID Antroquinonol
    Other Name: Antroquinonol 100mg
  • Drug: Antroquinonol capsule 200mg
    Patients will receive 12-week of 100mg BID Antroquinonol
    Other Name: Antroquinonol 200mg
  • Drug: Placebo oral capsule
    Patients will receive 12-week of 100mg BID Antroquinonol placebo
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Antroquinonol capsule 100mg
    Patients will receive 12-week of 50mg BID Antroquinonol
    Intervention: Drug: Antroquinonol capsule 100mg
  • Experimental: Antroquinonol capsule 200mg
    Patients will receive 12-week of 100mg BID Antroquinonol
    Intervention: Drug: Antroquinonol capsule 200mg
  • Placebo Comparator: Placebo oral capsule
    Patients will receive 12-week of 50mg BID Antroquinonol placebo
    Intervention: Drug: Placebo oral capsule
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: October 1, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 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. GOT or GPT ≧ 25 IU
  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

    1. White blood cell count less than 2500 cells/uL
    2. Absolute neutrophil count (ANC) less than 1,000 cells/mm3 (less than 750 mm3 for African or African-American subjects)
    3. Hemoglobin less than 12 g/dL for males, less than 11 g/dL for females
    4. 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: Wei C- C, M.D. +886-4 24739595 ext 56226 wei3228@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04112147
Other Study ID Numbers  ICMJE CS18018
Has Data Monitoring Committee Yes
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 Not Provided
Responsible Party Cheng-Chung Wei, Chung Shan Medical University
Study Sponsor  ICMJE Cheng-Chung Wei
Collaborators  ICMJE Golden Biotechnology Corporation
Investigators  ICMJE
Principal Investigator: Wei C- C, M.D. Chung Shan Medical University
PRS Account Chung Shan Medical University
Verification Date October 2019

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