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

• Sponsor: Dong-A ST Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05957380
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20.4
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Drug: DA-2803; Drug: DA-2803-R; Drug: Placebo of DA-2803; Drug: Placebo of DA-2803-R	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 20, 2023
• Anticipated Primary Completion Date: Feb 25, 2024
• Anticipated Study Completion Date: Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group	Drug: DA-2803; All participants are administered one tablet per day for 48 weeks; Drug: Placebo of DA-2803-R; All participants are administered one tablet per day for 48 weeks
Experimental: Reference group	Drug: DA-2803-R; All participants are administered one tablet per day for 48 weeks; Drug: Placebo of DA-2803; All participants are administered one tablet per day for 48 weeks

Outcome Measures

Primary Outcome Measures

1. HBV DNA(log10 IU/mL) change [48 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Catholic University of Korea, Seoul	Seoul		Korea, Republic of

Sponsors and Collaborators

• Dong-A ST Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dong-A ST Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05957380
• Other Study ID Numbers: DA2803_HB_IV
• First Posted: Jul 24, 2023
• Last Update Posted: Jul 24, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis

Study Results

No Results Posted as of Jul 24, 2023