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

Phase 4

Completed

• Conditions: Hepatitis B
• Interventions: Drug: DA-2803; Drug: DA-2803-R; Drug: Placebo of DA-2803-R; Drug: Placebo of DA-2803

• Registration Number: NCT05957380
• Lead Sponsor: Dong-A ST Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-20
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-24
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	DA-2803	-
Treatment group	Placebo of DA-2803-R	-
Reference group	DA-2803-R	-
Reference group	Placebo of DA-2803	-

Primary Outcome Measures

Name	Time	Method
HBV DNA(log10 IU/mL) change	48 weeks	HBV DNA(log10 IU/mL) change compared to baseline

Trial Locations

Locations (1)

The Catholic University of Korea, Seoul; 🇰🇷 Seoul, Korea, Republic of