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

NCT04112147 | Unknown Phase 2 DMC

• 1 other identifier: CS18018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis B

Keywords

antroquinonol, Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• serum hapatitis B virus DNA level

  Week 0, Week 4, Week 8 and Week 12

• hepatitis B surface antigen

  Week 0, Week 4 and Week 8

• Fibrosis-4(FIB-4) scale

  Week 0 and Week 12

• Hepatitis B surface antigen loss (HBeAg loss)

  Week 12

• glutamate oxaloacetate transaminase (GOT)

  Week 0 and Week 12

Study Arms (3)

Antroquinonol capsule 100mg

EXPERIMENTAL

Patients will receive 12-week of 50mg BID Antroquinonol

Drug: Antroquinonol capsule 100mg

Antroquinonol capsule 200mg

EXPERIMENTAL

Patients will receive 12-week of 100mg BID Antroquinonol

Drug: Antroquinonol capsule 200mg

Placebo oral capsule

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Interventions

Antroquinonol capsule 100mg DRUG

Patients will receive 12-week of 50mg BID Antroquinonol

Also known as: Antroquinonol 100mg

Antroquinonol capsule 100mg

Antroquinonol capsule 200mg DRUG

Patients will receive 12-week of 100mg BID Antroquinonol

Also known as: Antroquinonol 200mg

Antroquinonol capsule 200mg

Placebo oral capsule DRUG

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

Also known as: Placebo

Placebo oral capsule

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.
• GOT or GPT ≧ 25 IU
• 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
• 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)

Sponsors & Collaborators

• Cheng-Chung Wei: lead
• Golden Biotechnology Corporation: collaborator

Study Sites (1)

Chung Shan Medical University hospital

Taichung, 402, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

antroquinonol

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei C- C, M.D.

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei C- C, M.D.

CONTACT

+886-4 24739595; wei3228@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chung Shan Medical University Hospital

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 2, 2019
• Study Start: August 10, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 2, 2019

Record last verified: 2019-10

Locations

TW (1)