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

Last updated: October 21, 2024
Sponsor: Dong-A ST Co., Ltd.
Overall Status: Completed

Phase

4

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

Placebo of DA-2803

DA-2803

Placebo of DA-2803-R

Clinical Study ID

NCT05957380
DA2803_HB_IV
  • Ages > 19
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 ChronicHepatitis B

  • The subjects whose HBV DNA above 20,000 IU/mL when HBeAg positive or above 2,000IU/mL when HBeAg negative or positive when has history of Chronic Hepatitis B

  • The subjects completely understood the clinical trial through detailed explanationpresented, determined to participate in the clinical trial spontaneously, and agreedto observe precautions suggested thereby through written consent

Exclusion

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 beHepatocelluar carcinoma

Study Design

Total Participants: 120
Treatment Group(s): 4
Primary Treatment: Placebo of DA-2803
Phase: 4
Study Start date:
March 20, 2023
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • The Catholic University of Korea, Seoul

    Seoul,
    Korea, Republic of

    Site Not Available

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