- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04112147
A Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B
A Randomized, Double-Blind, Dosing-Ranging, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan, 402
- Recruiting
- Chung Shan Medical University Hospital
-
Contact:
- Wei C- C, M.D.
- Phone Number: 56226 +886-4 24739595
- Email: wei3228@gmail.com
-
Contact:
- Lin C- P, M.D.
- Phone Number: 38315 +886-4 24739595
- Email: anitayen1971@yahoo.com.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria -
- 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
Exclusion criteria -
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)
- Solid organ transplantation
- Current drug or alcohol abuse
- Pregnancy or lactation
- Under hepatitis B antiviral or interferon treatment within 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Antroquinonol capsule 100mg
Patients will receive 12-week of 50mg BID Antroquinonol
|
Patients will receive 12-week of 50mg BID Antroquinonol
Other Names:
|
EXPERIMENTAL: Antroquinonol capsule 200mg
Patients will receive 12-week of 100mg BID Antroquinonol
|
Patients will receive 12-week of 100mg BID Antroquinonol
Other Names:
|
PLACEBO_COMPARATOR: Placebo oral capsule
Patients will receive 12-week of 50mg BID Antroquinonol placebo
|
Patients will receive 12-week of 100mg BID Antroquinonol placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quantitative hepatitis B surface antigen (Log qHBsAg)
Time Frame: Week 0 and Week 12
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum hapatitis B virus DNA level
Time Frame: Week 0, Week 4, Week 8 and Week 12
|
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
|
hepatitis B surface antigen
Time Frame: Week 0, Week 4 and Week 8
|
Change from baseline quantitative hepatitis B surface antigen at Week 4 and Week 8
|
Week 0, Week 4 and Week 8
|
Fibrosis-4(FIB-4) scale
Time Frame: Week 0 and Week 12
|
Changes from baseline FIB-4 scale at Week 12
|
Week 0 and Week 12
|
Hepatitis B surface antigen loss (HBeAg loss)
Time Frame: Week 12
|
Percentage of HBeAg loss at Week 12
|
Week 12
|
glutamate oxaloacetate transaminase (GOT)
Time Frame: Week 0 and Week 12
|
Change from baseline GOT at Week 12
|
Week 0 and Week 12
|
Glutamic Pyruvic Transaminase (GPT)
Time Frame: Week 0 and Week 12
|
Change from baseline GPT at Week 12
|
Week 0 and Week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Physiological Effects of Drugs
- Micronutrients
- Ubiquinone
Other Study ID Numbers
- CS18018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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