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

Summary

Participation Requirements

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 obtai...

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.

Tracking Information