A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B

NCT03625102 | Completed Phase 2

• 1 other identifier: GHHBV-2-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatitis B virus infection is a worldwide disease and is still the most common cause of hepatocellular carcinoma (HCC).Existing treatments for hepatitis B infection have various side-effects including renal toxicity and drug resistance or failure.

Conditions

HBV

Keywords

Antroquinonol; Hocena

Outcome Measures

Primary Outcomes (1)

• Percentage

  The percentage improvement between baseline and day 85 in quantitative HBsAg.

  12 weeks

Secondary Outcomes (4)

• IU/mL

  4 week

• score

  12 week

• Unit/L

  4 week

• Unit /L

  4 week

Study Arms (3)

Antroquinonol 100 mg PO BID

EXPERIMENTAL

Antroquinonol (Hocena) 50mg/capsule. 2 capsules antroquinonol, twice a day.

Drug: Antroquinonol

Antroquinonol 50 mg PO BID

EXPERIMENTAL

Antroquinonol (Hocena) 50mg/capsule. 1 capsule antroquinonol and 1 capsule placebo,twice a day.

Drug: Antroquinonol; Other: placebo

Placebo

PLACEBO COMPARATOR

Placebo capsule, 2 capsules placebo, twice a day

Other: placebo

Interventions

Antroquinonol DRUG

Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.

Also known as: Hocena

Antroquinonol 100 mg PO BID; Antroquinonol 50 mg PO BID

placebo OTHER

The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects

Antroquinonol 50 mg PO BID; Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• AST or ALT≧25 IU and ALT\<5xULN
• Female subject must use effective methods of contraception.
• No abnormal finding of clinical relevance
• Written informed consent

You may not qualify if:

• 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 A、 White blood cell count less than 2500 cells/uL B、 Absolute neutrophil count (ANC) less than 1,000 cells/mm3 (less than 750 mm3 for African or African-American subjects) C、 Hemoglobin less than 12 g/dL for males, less than 11 g/dL for females D、 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

Sponsors & Collaborators

• Golden Biotechnology Corporation: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Interventions

antroquinonol

Study Officials

• Ching-Pin Lin, MD

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-center, phase IIa, double blind, and randomized, placebo-controlled trial of Antroquinonol in patients with hepatitis B infection. Subjects with diagnosis of hepatitis B meet inclusion/exclusion criteria will be randomized into 3 groups: 1. Antroquinonol 100 mg PO BID 2. Antroquinonol 50 mg PO BID 3. Placebo

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 10, 2018
• Study Start: August 1, 2018
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)