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

NCT ID: NCT04112147

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-10
• Study Completion Date: 2020-06-30

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Antroquinonol capsule 100mg

Patients will receive 12-week of 50mg BID Antroquinonol

Group Type: EXPERIMENTAL

Antroquinonol capsule 100mg

Intervention Type: DRUG

Patients will receive 12-week of 50mg BID Antroquinonol

Antroquinonol capsule 200mg

Patients will receive 12-week of 100mg BID Antroquinonol

Group Type: EXPERIMENTAL

Antroquinonol capsule 200mg

Intervention Type: DRUG

Patients will receive 12-week of 100mg BID Antroquinonol

Placebo oral capsule

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

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

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

Interventions

Antroquinonol capsule 100mg

Patients will receive 12-week of 50mg BID Antroquinonol

Intervention Type: DRUG

Antroquinonol capsule 200mg

Patients will receive 12-week of 100mg BID Antroquinonol

Intervention Type: DRUG

Placebo oral capsule

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

Intervention Type: DRUG

Other Intervention Names

Antroquinonol 100mg; Antroquinonol 200mg; Placebo

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Golden Biotechnology Corporation

INDUSTRY

Sponsor Role: collaborator

Cheng-Chung Wei

OTHER

Sponsor Role: lead

Responsible Party

Cheng-Chung Wei

Chung Shan Medical University Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wei C- C, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

Chung Shan Medical University hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Wei C- C, M.D.

Role: CONTACT

wei3228@gmail.com

+886-4 24739595 ext. 56226

Facility Contacts

Lin C- P, M.D.

Role: primary

anitayen1971@yahoo.com.tw

+886-4 24739595 ext. 38315

Wei C- C, M.D.

Role: backup

wei3228@gmail.com

+886-4 24739595 ext. 56226

Other Identifiers

CS18018

Identifier Type: -

Identifier Source: org_study_id