Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 in t… (NCT07673068) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 in the Treatment of Chronic Hepatitis B
32 participantsStarted 2026-05-31
Plain-language summary
This is a multicenter, open-label, non-randomized, Phase 1 clinical study with single-dose and multiple-dose dose-escalation cohorts. The study is designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of TVAX-028 in patients with chronic hepatitis B virus infection
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Subjects voluntarily sign the informed consent, fully understand the study content, and are willing and able to comply with all trial procedures.
* 2\. Male or female, aged 18 to 65 years.
* 3\. Has a clinical diagnosis of chronic hepatitis B virus infection based on protocol-defined criteria.
* 4\. Is receiving stable antiviral treatment with a single nucleos(t)ide analogue before enrollment. Has adequately suppressed HBV DNA and acceptable liver function based on protocol-defined criteria before the first administration of adjuvant or TVAX-028.
* 5\. Has HBeAg-negative chronic hepatitis B virus infection based on protocol-defined criteria.
* 6\. Has hepatitis B surface antigen (HBsAg) levels within the protocol-defined range before the first administration of adjuvant or TVAX-028.
* 7\. Has no evidence of autoimmune liver disease based on protocol-defined testing and investigator assessment.
* 8\. Participants of childbearing potential must agree to use effective contraception for the protocol-defined period.
Exclusion Criteria:
* 1\. Has liver disease other than chronic hepatitis B virus infection that may interfere with study participation or interpretation of study results
* 2\. Has evidence or suspected evidence of hepatocellular carcinoma, cirrhosis, clinically significant hepatic space-occupying lesions, or clinically significant liver fibrosis based on imaging, laboratory testing, or non-invasive liver assessment.
* 3\. Has clinically sig…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events
Timeframe: Through the end of the safety follow-up period, an average of 60 weeks
2
Number of participants with dose-limiting toxicities
Timeframe: Through the end of the safety follow-up period, an average of 60 weeks
Trial details
NCT IDNCT07673068
SponsorGrand Theravac Life Sciences (Nanjing) Co., Ltd.