Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients

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

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

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Drug: DA-2803; Drug: Placebo of DA-2803-R; Drug: DA-2803-R; Drug: Placebo of DA-2803

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group	Drug: DA-2803; All participants are administered one tablet per day for 48 weeks; Drug: Placebo of DA-2803-R; All participants are administered one tablet per day for 48 weeks
Experimental: Reference group	Drug: DA-2803-R; All participants are administered one tablet per day for 48 weeks; Drug: Placebo of DA-2803; All participants are administered one tablet per day for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBV DNA(log10 IU/mL) change	HBV DNA(log10 IU/mL) change compared to baseline	48 weeks

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis A; Hepatitis; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: DA2803_HB_IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No