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Not yet recruiting NCT07673068

Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 in the Treatment of Chronic Hepatitis B

Phase I Interventional HBV Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TVAX-028, Adjuvant.
Who it may be relevant to
Registry conditions: HBV Infection. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 Injection in Patients With Chronic Hepatitis B

Overview

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

Interventions

  • Drug TVAX-028
    TVAX-028 will be administered with adjuvant at low, medium, or high dose levels in the investigational dose groups.
  • Other Adjuvant
    Adjuvant will be administered alone in the adjuvant group

Primary outcome measures

  • Number of participants with adverse events [Time frame: Through the end of the safety follow-up period, an average of 60 weeks]
  • Number of participants with dose-limiting toxicities [Time frame: Through the end of the safety follow-up period, an average of 60 weeks]

Eligibility criteria

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 significant abnormalities in laboratory tests, including but not limited to liver function, renal function, hematology, coagulation, or electrolyte parameters, based on protocol-defined criteria.
  • 4\. Has received interferon or pegylated interferon treatment within the protocol-defined period before the first administration of adjuvant or TVAX-028, or plans to receive such treatment during the study.
  • 5\. Has received immunosuppressive therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028.
  • 6\. Has received corticosteroid therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for permitted topical or inhaled corticosteroids.
  • 7\. Has clinically significant cardiovascular, renal, pancreatic, or other systemic disease that may increase study risk or interfere with study assessments.
  • 8\. Has inadequately controlled diabetes mellitus or hypertension based on protocol-defined criteria.
  • 9\. Has evidence of clinically significant co-infection, including hepatitis C virus, hepatitis D virus, human immunodeficiency virus, or active syphilis infection.
  • 10\. Has a history of malignancy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for conditions permitted by the protocol.
  • 11\. Has previously received organ transplantation.
  • 12\. Has a history of severe drug and food allergy, or is known to be allergic to any component of the investigational product or related products.
  • 13\. Has a history of drug abuse or clinically significant alcohol abuse within the protocol-defined period before the first dose.
  • 14\. Has a history or current diagnosis of psychiatric disease, severe depression, or other condition that may affect compliance with study procedures.
  • 15\. Has a history of severe allergy, or is known or suspected to be allergic to any component of the investigational product, adjuvant, or related products.
  • 16\. Has participated in another clinical trial of an investigational drug, biologic, medical device, or vaccine within the protocol-defined period before the first administration of adjuvant or TVAX-028.
  • 17\. Is pregnant or breastfeeding.
  • 18\. Is considered by the investigator to be unsuitable for participation in this study for any other reason.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07673068 · YDSWX(TVAX-028)-001(I)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗