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

NCT05957380 | Completed Phase 4

• 1 other identifier: DA2803_HB_IV
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• HBV DNA(log10 IU/mL) change

  HBV DNA(log10 IU/mL) change compared to baseline

  48 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Reference group

EXPERIMENTAL

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

Interventions

DA-2803 DRUG

All participants are administered one tablet per day for 48 weeks

Treatment group

DA-2803-R DRUG

All participants are administered one tablet per day for 48 weeks

Reference group

Placebo of DA-2803 DRUG

All participants are administered one tablet per day for 48 weeks

Reference group

Placebo of DA-2803-R DRUG

All participants are administered one tablet per day for 48 weeks

Treatment group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

The Catholic University of Korea, Seoul

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: March 20, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)