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

Primary Purpose

Chronic Hepatitis B

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Antroquinonol capsule 100mg

Antroquinonol capsule 200mg

Placebo oral capsule

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring antroquinonol, Chronic Hepatitis B

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria -

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
BMI≦35
HBsAg≧10 IU/mL and HBV DNA≧2000 IU/mL.
GOT or GPT ≧ 25 IU
Female subject must use effective methods of contraception
No abnormal finding of clinical relevance
Written informed consent

Exclusion criteria -

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
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
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).
Immunodeficiency disorders or severe autoimmune disease
Severe pulmonary disorders or significant cardiac diseases
Gastrointestinal disorder with post-operative condition that could interfere with drug absorption
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
Any malignancy diagnosed within 5 years or evidence of hepatocellular carcinoma (e.g., α fetoprotein > 50ng/mL or radiologic evidence)
Solid organ transplantation
Current drug or alcohol abuse
Pregnancy or lactation
Under hepatitis B antiviral or interferon treatment within 3 months

Sites / Locations

Chung Shan Medical University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Antroquinonol capsule 100mg

Antroquinonol capsule 200mg

Placebo oral capsule

Arm Description

Patients will receive 12-week of 50mg BID Antroquinonol

Patients will receive 12-week of 100mg BID Antroquinonol

Patients will receive 12-week of 50mg BID Antroquinonol placebo

Outcomes

Primary Outcome Measures

quantitative hepatitis B surface antigen (Log qHBsAg)

The primary endpoint is the change from baseline in quantitative hepatitis B surface antigen (Log qHBsAg) at Week 12.

Secondary Outcome Measures

serum hapatitis B virus DNA level

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

Change from baseline quantitative hepatitis B surface antigen at Week 4 and Week 8

Fibrosis-4(FIB-4) scale

Changes from baseline FIB-4 scale at Week 12

Hepatitis B surface antigen loss (HBeAg loss)

Percentage of HBeAg loss at Week 12

glutamate oxaloacetate transaminase (GOT)

Change from baseline GOT at Week 12

Glutamic Pyruvic Transaminase (GPT)

Change from baseline GPT at Week 12

Full Information

NCT ID

NCT04112147

First Posted

October 1, 2019

Last Updated

October 1, 2019

Sponsor

Cheng-Chung Wei

Collaborators

Golden Biotechnology Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04112147

Brief Title

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

Official Title

A Randomized, Double-Blind, Dosing-Ranging, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 10, 2018 (Actual)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Cheng-Chung Wei

Collaborators

Golden Biotechnology Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

Keywords

antroquinonol, Chronic Hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Antroquinonol capsule 100mg

Arm Type

Experimental

Arm Description

Patients will receive 12-week of 50mg BID Antroquinonol

Arm Title

Antroquinonol capsule 200mg

Arm Type

Experimental

Arm Description

Patients will receive 12-week of 100mg BID Antroquinonol

Arm Title

Placebo oral capsule

Arm Type

Placebo Comparator

Arm Description

Patients will receive 12-week of 50mg BID Antroquinonol placebo

Intervention Type

Drug

Intervention Name(s)

Antroquinonol capsule 100mg

Other Intervention Name(s)

Antroquinonol 100mg

Intervention Description

Patients will receive 12-week of 50mg BID Antroquinonol

Intervention Type

Drug

Intervention Name(s)

Antroquinonol capsule 200mg

Other Intervention Name(s)

Antroquinonol 200mg

Intervention Description

Patients will receive 12-week of 100mg BID Antroquinonol

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Other Intervention Name(s)

Placebo

Intervention Description

Patients will receive 12-week of 100mg BID Antroquinonol placebo

Primary Outcome Measure Information:

Title

quantitative hepatitis B surface antigen (Log qHBsAg)

Description

The primary endpoint is the change from baseline in quantitative hepatitis B surface antigen (Log qHBsAg) at Week 12.

Time Frame

Week 0 and Week 12

Secondary Outcome Measure Information:

Title

serum hapatitis B virus DNA level

Description

Change from baseline serum hapatitis B virus DNA level(HBV DNA as measured in IU/mL) at Week 4, Week 8 and Week 12

Time Frame

Week 0, Week 4, Week 8 and Week 12

Title

hepatitis B surface antigen

Description

Change from baseline quantitative hepatitis B surface antigen at Week 4 and Week 8

Time Frame

Week 0, Week 4 and Week 8

Title

Fibrosis-4(FIB-4) scale

Description

Changes from baseline FIB-4 scale at Week 12

Time Frame

Week 0 and Week 12

Title

Hepatitis B surface antigen loss (HBeAg loss)

Description

Percentage of HBeAg loss at Week 12

Time Frame

Week 12

Title

glutamate oxaloacetate transaminase (GOT)

Description

Change from baseline GOT at Week 12

Time Frame

Week 0 and Week 12

Title

Glutamic Pyruvic Transaminase (GPT)

Description

Change from baseline GPT at Week 12

Time Frame

Week 0 and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria - 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 BMI≦35 HBsAg≧10 IU/mL and HBV DNA≧2000 IU/mL. GOT or GPT ≧ 25 IU Female subject must use effective methods of contraception No abnormal finding of clinical relevance Written informed consent Exclusion criteria - Evidence of hepatic decompensation such as: Coagulopathy defined as prolongation of prothrombin time greater than 3 seconds Total bilirubin of 2 times the upper limit of normal FIB-4 of 3.25 or greater Abnormal hematological and biochemical parameters at screening White blood cell count less than 2500 cells/uL Absolute neutrophil count (ANC) less than 1,000 cells/mm3 (less than 750 mm3 for African or African-American subjects) Hemoglobin less than 12 g/dL for males, less than 11 g/dL for females Estimated GFR less than 50 mL/min 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). Immunodeficiency disorders or severe autoimmune disease Severe pulmonary disorders or significant cardiac diseases Gastrointestinal disorder with post-operative condition that could interfere with drug absorption 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 Any malignancy diagnosed within 5 years or evidence of hepatocellular carcinoma (e.g., α fetoprotein > 50ng/mL or radiologic evidence) Solid organ transplantation Current drug or alcohol abuse Pregnancy or lactation Under hepatitis B antiviral or interferon treatment within 3 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei C- C, M.D.

Phone

+886-4 24739595

Ext

56226

wei3228@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei C- C, M.D.

Organizational Affiliation

Chung Shan Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chung Shan Medical University hospital

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lin C- P, M.D.

Phone

+886-4 24739595

Ext

38315

anitayen1971@yahoo.com.tw

First Name & Middle Initial & Last Name & Degree

Wei C- C, M.D.

Phone

+886-4 24739595

Ext

56226

wei3228@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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