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

Dong-A ST

Status and phase: Completed; Phase 4

Conditions: Hepatitis B

Treatments: Drug: DA-2803-R; Drug: Placebo of DA-2803-R; Drug: Placebo of DA-2803; Drug: DA-2803

Study type: Interventional

Funder types: Industry

Identifiers

NCT05957380

DA2803_HB_IV

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Treatment group

Experimental group

Treatment:

Drug: DA-2803

Drug: Placebo of DA-2803-R

Reference group

Experimental group

Treatment:

Drug: Placebo of DA-2803

Drug: DA-2803-R