A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs (NCT07069569) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
China127 participantsStarted 2025-05-30
Plain-language summary
This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
* Aged between 18 and 65 years at the time of signing the ICF;
* Body mass index (BMI) within the range of 18-30 kg/ m2;
* HBeAg negative at screening;
* HBsAg or HBV DNA positive for at least 6 months;
* Continue antiviral therapy with a single nucleoside (t) ide analogue for more than 6 months prior to screening;
* Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
* Effective contraception as required.
Exclusion Criteria:
* Participants who are not eligible for treatment with Peg-IFN/recombinant hepatitis B vaccine;
* Clinically significant abnormalities other than a history of chronic HBV infection;
* Concomitant clinically significant other liver diseases;
* Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to screening;
* HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive;
* Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) \> 9.0 kPa;
* Previous/current manifestations of hepatic decompensation;
* Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein concentration (AFP) ≥ 20 ng/mL at screening;
* Obviously abnormal laboratory test results;
* History of vasculitis or presence of signs, symptoms, or laborato…
What they're measuring
1
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.