A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients

Dong-A ST Co., Ltd.1 site in 1 country120 target enrollmentMarch 20, 2023

ConditionsHepatitis B

InterventionsDA-2803 Placebo of DA-2803-R DA-2803-R Placebo of DA-2803

DrugsDA-2803 DA-2803-R Placebo of DA-2803 Placebo of DA-2803-R

Overview

Phase: Phase 4
Intervention: DA-2803
Conditions: Hepatitis B
Sponsor: Dong-A ST Co., Ltd.
Enrollment: 120
Locations: 1
Primary Endpoint: HBV DNA(log10 IU/mL) change
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a multi-center, double-blind, active-controlled, randomized, parallel clinical study to evaluate the efficacy and safety of DA-2803 in chronic hepatitis B subjects

Registry

clinicaltrials.gov

Start Date

March 20, 2023

End Date

September 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dong-A ST Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult male and female subjects of ages in the range over 19
•The subjects HBsAg positive for at least 6 months or has history of Chronic Hepatitis B
•The subjects whose HBV DNA above 20,000 IU/mL when HBeAg positive or above 2,000 IU/mL when HBeAg negative or positive when has history of Chronic Hepatitis B
•The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent

Exclusion Criteria

•The subjects who have been infected with HCV, HDV, HIV
•The subjects who have Hemochromatosis, Wilson's disease, autoimmune liver disease, and α-1 antitrypsin deficiency
•The subjects whose α-fetoprotein over 50 ng/mL and who are persumed to be Hepatocelluar carcinoma