A Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B

Overview

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

Full Title of Study: “A Randomized, Double-Blind, Dosing-Ranging, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 30, 2020

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.

Interventions

  • Drug: Antroquinonol capsule 100mg
    • Patients will receive 12-week of 50mg BID Antroquinonol
  • Drug: Antroquinonol capsule 200mg
    • Patients will receive 12-week of 100mg BID Antroquinonol
  • Drug: Placebo oral capsule
    • Patients will receive 12-week of 100mg BID Antroquinonol placebo

Arms, Groups and Cohorts

  • Experimental: Antroquinonol capsule 100mg
    • Patients will receive 12-week of 50mg BID Antroquinonol
  • Experimental: Antroquinonol capsule 200mg
    • Patients will receive 12-week of 100mg BID Antroquinonol
  • Placebo Comparator: Placebo oral capsule
    • Patients will receive 12-week of 50mg BID Antroquinonol placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cheng-Chung Wei
  • Collaborator
    • Golden Biotechnology Corporation
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Cheng-Chung Wei, Chung Shan Medical University Hospital – Chung Shan Medical University
  • Overall Official(s)
    • Wei C- C, M.D., Principal Investigator, Chung Shan Medical University
  • Overall Contact(s)
    • Wei C- C, M.D., +886-4 24739595, wei3228@gmail.com

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