NCT05957380CompletedPhase 4
Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
Source: ClinicalTrials.gov · Last updated 23 Oct 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 14 Jul 2023
- Start date
- 20 Mar 2023
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Dong-A ST Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT05957380
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 120
- From 20 Mar 2023 to the primary completion date, 30 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- The subjects whose α-fetoprotein over 50 ng/mL and who are persumed to be Hepatocelluar carcinoma
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Catholic University of Korea, Seoul Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.