A Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B
- Conditions
- Chronic Hepatitis B
- Interventions
- Registration Number
- NCT04112147
- Lead Sponsor
- Cheng-Chung Wei
- 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
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antroquinonol capsule 100mg Antroquinonol capsule 100mg Patients will receive 12-week of 50mg BID Antroquinonol Antroquinonol capsule 200mg Antroquinonol capsule 200mg Patients will receive 12-week of 100mg BID Antroquinonol Placebo oral capsule Placebo oral capsule Patients will receive 12-week of 50mg BID Antroquinonol placebo
- Primary Outcome Measures
Name Time Method quantitative hepatitis B surface antigen (Log qHBsAg) Week 0 and Week 12 The primary endpoint is the change from baseline in quantitative hepatitis B surface antigen (Log qHBsAg) at Week 12.
- Secondary Outcome Measures
Name Time Method hepatitis B surface antigen Week 0, Week 4 and Week 8 Change from baseline quantitative hepatitis B surface antigen at Week 4 and Week 8
Hepatitis B surface antigen loss (HBeAg loss) Week 12 Percentage of HBeAg loss at Week 12
Glutamic Pyruvic Transaminase (GPT) Week 0 and Week 12 Change from baseline GPT at Week 12
Fibrosis-4(FIB-4) scale Week 0 and Week 12 Changes from baseline FIB-4 scale at Week 12
glutamate oxaloacetate transaminase (GOT) Week 0 and Week 12 Change from baseline GOT at Week 12
serum hapatitis B virus DNA level 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
Related Research Topics
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Trial Locations
- Locations (1)
Chung Shan Medical University hospital
🇨🇳Taichung, Taiwan