Status:
ACTIVE_NOT_RECRUITING
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in Treated Patients With Chronic Hepatitis B
Lead Sponsor:
Grand Theravac Life Sciences (Nanjing) Co., Ltd.
Conditions:
Chronic Hepatitis B Virus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The objective of this study was to evaluate the efficacy and safety of TVAX-008 Injection in a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial in NAs-...
Eligibility Criteria
Inclusion
- Voluntary signing of the informed consent form, understanding of the study and willingness to follow and ability to complete all trial procedures;
- Male or female, age 18-65 (including thresholds)
- Clinically diagnosed chronic hepatitis B (HBsAg positive serum ≥6 months)
- Subjects receiving antiviral therapy with a single nucleotide analogue such as tenofovir fumarate (TAF), tenofovir amitidine (TMF), tenofovir disotil fumarate (TDF), or entecavir (ETV) and HBV DNA\<100 IU/mL within 28 days prior to first dose of investigational product
- HBeAg negative within 28 days prior to first use of investigational product
- HBsAg\>0.05 IU/mL and HBsAg\<100 IU/mL within 28 days prior to first use of investigational product
Exclusion
- Clinically important chronic diseases other than chronic hepatitis B that, in the opinion of the investigator, make the patient unsuitable for participation in the study
- Laboratory indicators or symptoms meet one or more of the following: 1) blood phosphorus \<0.65 mmol/L; 2) serum albumin \<35 g/L; 3) total bilirubin\> 1.5 × ULN; 4) hemoglobin \<90 g/L; 5) international normalized ratio of prothrombin time ≥ 1.5; 6) ascites, varicose vein bleeding, hepatorenal syndrome, hepatic encephalopathy or liver failure; 7) platelet count \<90 × 109/L; INR 8) absolute neutrophil count \<1.2 × 109/L; 9) serum creatinine\> 1.5 × ULN or creatinine clearance \<50 mL/min/1.73m2; imaging findings showing cirrhosis or liver space-occupying lesions (except liver cysts or hemangiomas)
- 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
- Use of immunosuppressants within 6 months prior to first use of investigational product
- Treatment with corticosteroids (other than topical or inhaled corticosteroids) for 1 week or more within 6 months prior to first use of investigational product
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07190742
Start Date
June 1 2023
End Date
May 1 2026
Last Update
September 24 2025
Active Locations (1)
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1
Peking University first hospital
Beijing, China, 10000