TVAX-008 Injection for Chronic Hepatitis B Patients
TVAX-008
+ Placebo
Treatment Study
Summary
Study start date: January 22, 2025
Actual date on which the first participant was enrolled.This study aims to test a new treatment called TVAX-008, which is given as an injection, for people with chronic Hepatitis B. It focuses on those who have specific levels of the Hepatitis B surface antigen in their blood, whether they have been treated before with certain drugs called siRNA or ASO, or have never had treatment for Hepatitis B infection. The goal is to see if TVAX-008 can effectively manage the virus and improve patient outcomes, addressing a significant need for better treatment options in this condition. In this study, participants receive either the TVAX-008 injection or a placebo, which is a harmless substance, without knowing which one they are getting, to ensure unbiased results. Researchers closely monitor participants to evaluate how well the treatment works and its safety. By comparing the health outcomes between the group receiving the real treatment and the placebo group, the study assesses the potential benefits and any side effects of TVAX-008.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: \- aged 18\~65 ； Serum HBsAg positive ≥ 6 months； HBeAg negative； Exclusion Criteria: * Treatment with interferon or pegylated interferon within 12 weeks prior to first use of investigational product; or planned treatment with interferon or pegylated interferon during the trial;
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location