Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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


Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Antroquinonol capsule 100mg Drug: Antroquinonol capsule 200mg Drug: Placebo oral capsule Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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 10, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antroquinonol capsule 100mg
Patients will receive 12-week of 50mg BID Antroquinonol
Drug: Antroquinonol capsule 100mg
Patients will receive 12-week of 50mg BID Antroquinonol
Other Name: Antroquinonol 100mg

Experimental: Antroquinonol capsule 200mg
Patients will receive 12-week of 100mg BID Antroquinonol
Drug: Antroquinonol capsule 200mg
Patients will receive 12-week of 100mg BID Antroquinonol
Other Name: Antroquinonol 200mg

Placebo Comparator: Placebo oral capsule
Patients will receive 12-week of 50mg BID Antroquinonol placebo
Drug: Placebo oral capsule
Patients will receive 12-week of 100mg BID Antroquinonol placebo
Other Name: Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Fibrosis-4(FIB-4) scale [ Time Frame: Week 0 and Week 12 ]
    Changes from baseline FIB-4 scale at Week 12

  4. Hepatitis B surface antigen loss (HBeAg loss) [ Time Frame: Week 12 ]
    Percentage of HBeAg loss at Week 12

  5. glutamate oxaloacetate transaminase (GOT) [ Time Frame: Week 0 and Week 12 ]
    Change from baseline GOT at Week 12

  6. Glutamic Pyruvic Transaminase (GPT) [ Time Frame: Week 0 and Week 12 ]
    Change from baseline GPT at Week 12



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.


Layout table for eligibility information
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. 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

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): NCT04112147


Contacts
Layout table for location contacts
Contact: Wei C- C, M.D. +886-4 24739595 ext 56226 wei3228@gmail.com

Locations
Layout table for location information
Taiwan
Chung Shan Medical University hospital Recruiting
Taichung, Taiwan, 402
Contact: Lin C- P, M.D.    +886-4 24739595 ext 38315    anitayen1971@yahoo.com.tw   
Contact: Wei C- C, M.D.    +886-4 24739595 ext 56226    wei3228@gmail.com   
Sponsors and Collaborators
Cheng-Chung Wei
Golden Biotechnology Corporation
Investigators
Layout table for investigator information
Principal Investigator: Wei C- C, M.D. Chung Shan Medical University

Layout table for additonal information
Responsible Party: Cheng-Chung Wei, Chung Shan Medical University Hospital, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT04112147    
Other Study ID Numbers: CS18018
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheng-Chung Wei, Chung Shan Medical University:
antroquinonol, Chronic Hepatitis B
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Ubiquinone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs