NCT07876856Not yet recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
This is a study of sequential therapy with AHB-137 injection followed by TVAX-008 injection in participants living with Chronic Hepatitis B (CHB).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 9 Oct 2026
- Start date
- 31 Oct 2026
- Primary completion date
- 22 Sept 2028
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT07876856
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 105
- From 31 Oct 2026 to the primary completion date, 22 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received treatment with the relevant medication;
- 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;
Other illness
- Uncontrolled and stable clinically significant abnormalities or other serious diseases other than a history of chronic HBV infection;
- 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;
- Diseases associated with vascular inflammatory conditions;
- History of malignancy or ongoing assessment of possible malignancy;
- History of allergies, or allergic constitution;
- There are serious cardiovascular and cerebrovascular diseases;
Lab values
- Abnormal laboratory results;
- QT interval corrected heart rate (Fridericia method) abnormal;
Other
- Thyroid function abnormal;
- Inappropriate for participation in this trial as judged by the investigator.
Who the study is looking for
- Voluntarily participate in the study and sign the informed consent form, and comply with the requirements of the study protocol;
- 18-65 years of age (including boundary values) for men or women;
- 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;
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.