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

NCT ID: NCT05957380

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2024-09-30

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

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group

Group Type: EXPERIMENTAL

DA-2803

Intervention Type: DRUG

All participants are administered one tablet per day for 48 weeks

Placebo of DA-2803-R

Intervention Type: DRUG

All participants are administered one tablet per day for 48 weeks

Reference group

Group Type: EXPERIMENTAL

DA-2803-R

Intervention Type: DRUG

All participants are administered one tablet per day for 48 weeks

Placebo of DA-2803

Intervention Type: DRUG

All participants are administered one tablet per day for 48 weeks

Interventions

DA-2803

All participants are administered one tablet per day for 48 weeks

Intervention Type: DRUG

DA-2803-R

All participants are administered one tablet per day for 48 weeks

Intervention Type: DRUG

Placebo of DA-2803

All participants are administered one tablet per day for 48 weeks

Intervention Type: DRUG

Placebo of DA-2803-R

All participants are administered one tablet per day for 48 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Catholic University of Korea, Seoul

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DA2803_HB_IV

Identifier Type: -

Identifier Source: org_study_id