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

Cheng-Chung Wei

Status and phase: Unknown; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: Placebo oral capsule; Drug: Antroquinonol capsule 200mg; Drug: Antroquinonol capsule 100mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04112147

CS18018

Details and patient eligibility

About

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 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Antroquinonol capsule 100mg

Experimental group

Description:

Patients will receive 12-week of 50mg BID Antroquinonol

Treatment:

Drug: Antroquinonol capsule 100mg

Antroquinonol capsule 200mg

Experimental group

Description:

Patients will receive 12-week of 100mg BID Antroquinonol

Treatment:

Drug: Antroquinonol capsule 200mg

Placebo oral capsule

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral capsule