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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04112147
• Other study ID #: CS18018
• Status: Recruiting
• Phase: Phase 2
• Start date: August 10, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2019
• Source: Chung Shan Medical University
• Contact: Wei C- C, M.D.
• Phone: +886-4 24739595
• Email: wei3228[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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., a 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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Cheng-Chung Wei	Golden Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 0 and Week 12
Secondary	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	Week 0, Week 4, Week 8 and Week 12
Secondary	hepatitis B surface antigen	Change from baseline quantitative hepatitis B surface antigen at Week 4 and Week 8	Week 0, Week 4 and Week 8
Secondary	Fibrosis-4(FIB-4) scale	Changes from baseline FIB-4 scale at Week 12	Week 0 and Week 12
Secondary	Hepatitis B surface antigen loss (HBeAg loss)	Percentage of HBeAg loss at Week 12	Week 12
Secondary	glutamate oxaloacetate transaminase (GOT)	Change from baseline GOT at Week 12	Week 0 and Week 12
Secondary	Glutamic Pyruvic Transaminase (GPT)	Change from baseline GPT at Week 12	Week 0 and Week 12