Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analog… (NCT07246889) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)
China577 participantsStarted 2025-08-12
Plain-language summary
This study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.
Who can participate
Age range18 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;
* At least 18 years of age at the time of signing the ICF;
* Body mass index met the requirements;
* HBeAg negative at screening;
* HBsAg or HBV DNA positive for at least 6 months;
* Meet relevant requirements for NAs treatment;
* 100 IU/mL \< HBsAg ≤ 3000 IU/mL, HBV DNA \< 100 IU/mL and liver function indicators meet the requirements;
* Effective contraception as required.
Exclusion Criteria:
* Clinically significant abnormalities other than a history of chronic HBV infection;
* Concomitant clinically significant other liver diseases;
* Previous/current manifestations of hepatic decompensation;
* Significant hepatic fibrosis or cirrhosis;
* Presence of protocol-specified laboratory abnormalities;
* History of malignancy or ongoing assessment of possible malignancy;
* Those allergic to AHB-137 or its components;
* Participants with recent major trauma or major surgery, or planning 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;
* Inappropriate for participation in this trial as judged by the investigator.
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
Timeframe: 24 weeks after discontinuation of all CHB treatment