A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 1/2 Study to Evaluate AHB-137 Injection Followed by TVAX-008 Injection in Participants With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Analogs
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) in Phase I
Treatment-emergent adverse events (TEAEs) will be assessed during the protocol-defined observation period. The percentage of participants experiencing at least one TEAE will be reported.
From the first dose of study treatment through the last study visit (up to Week 72)
Percentage of Participants Achieving Clinical Cure (Functional Cure) at 24 Weeks After Discontinuation of All Chronic Hepatitis B Treatments in Phase II
Clinical cure is defined as HBsAg clearance (\<0.05 IU/mL) and sustained HBV DNA suppression (\<LLOQ), allowing transient viral rebound, at 24 weeks after discontinuation of all CHB treatments, regardless of HBsAb status. The percentage of participants achieving clinical cure will be reported.
24 weeks after discontinuation of all chronic hepatitis B treatments (up to Week 72)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Body mass index met the requirements;
HBeAg negative at screening;
Meet the relevant requirements for prior medications;
HBsAg and HBV DNA and liver function indicators meet the requirements;
Use contraception as required;
You may not qualify if:
Uncontrolled and stable clinically significant abnormalities or other serious diseases other than a history of chronic HBV infection;
Has received treatment with the relevant medication;
Participants with clinically significant relevant liver diseases, manifestations of liver function decompensation, history of extrahepatic diseases related to HBV immune status, liver fibrosis or cirrhosis, and confirmed or suspected liver cancer;
Any serious infection other than chronic hepatitis B infection requires intravenous anti-infective therapy;
HCV RNA positive, HIV antibody positive, syphilis positive within 12 months;
Abnormal laboratory results;
Diseases associated with vascular inflammatory conditions;
History of malignancy or ongoing assessment of possible malignancy;
History of allergies, or allergic constitution;
Recent major trauma or major surgery, or planned surgery;
Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
Prior/current use of prohibited medications;
Thyroid function abnormal;
There are serious cardiovascular and cerebrovascular diseases;
+1 more criteria
Contact the study team to confirm eligibility.
Disease Attributes
Pathologic Processes
Pathological Conditions, Signs and Symptoms
Organizing Pneumonia
Bronchiolitis Obliterans
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Graft vs Host Disease
Immune System Diseases
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 20, 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
Data Sharing
IPD Sharing
Will not share
Source record
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Source: ClinicalTrials.gov.
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