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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05957380
• Other study ID #: DA2803_HB_IV
• Status: Recruiting
• Phase: Phase 4
• Start date: March 20, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: July 2023
• Source: Dong-A ST Co., Ltd.
• Contact: Jeongwon Jang
• Phone: 82-1588-1511
• Email: garden[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: November 30, 2024
• Est. primary completion date: February 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 a-1 antitrypsin deficiency

• The subjects whose a-fetoprotein over 50 ng/mL and who are persumed to be Hepatocelluar carcinoma

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• DA-2803
All participants are administered one tablet per day for 48 weeks
• DA-2803-R
All participants are administered one tablet per day for 48 weeks
• Placebo of DA-2803
All participants are administered one tablet per day for 48 weeks
• Placebo of DA-2803-R
All participants are administered one tablet per day for 48 weeks

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Seoul	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV DNA(log10 IU/mL) change	HBV DNA(log10 IU/mL) change compared to baseline	48 weeks