A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participan… (NCT06993480) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
China20 participantsStarted 2025-07-15
Plain-language summary
AB-10-8005 is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues.
Who can participate
Age range18 Years – 55 Years
SexALL
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:
* Voluntarily participated in the study and signed an informed consent form;
* Aged between 18 and 55 years at the time of signing the informed consent form;
* Body mass index (BMI) within the range of 18-30 kg/ m2;
* HBeAg negative or positive at screening;
* HBsAg or HBV DNA positive for at least 6 months;
* Have been on continuous nucleos(t)ide analogues antiviral therapy for more than 6 months prior to screening;
* 100 IU/mL \< HBsAg ≤ 3000 IU/mL and HBV DNA \< 100 IU/mL at screening;
* Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
* Effective contraception as required.
Exclusion Criteria:
* Clinically significant abnormalities other than a history of CHB infection;
* Concomitant clinically significant other liver diseases;
* Any serious infection other than CHB infection requiring intravenous anti-infective therapy within 1 month prior to screening;
* Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
* Liver stiffness value (LSM) \> 9.0 kPa at screening;
* Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein (AFP) concentration ≥ 20 ng/mL at screening;
* Participants with confirmed or suspected hepatic decompensated hepatitis B cirrhosis;
* Liver biopsy at screening assessed severity of activity ≥ G3 grade and/or fibrosis reaching S4 stage;
* History of extrahepatic disease possibly related to HBV immune status;
* Ongoing or taking any immunosuppressive medication within 3 mo…
What they're measuring
1
Proportion of participants with serum HBsAg < limit of detection (LOD) 0.05 international unit per milliliter (IU/mL) and Hepatitis B Virus (HBV) DNA < lower limit of quantification (LLOQ) with or without HBsAb seroconversion.