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A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs

ConditionChronic Hepatitis B
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAusper Biopharma Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AHB-137

    Drug

    AHB-137 will be injected.

  • Peg-IFN

    Drug

    Peg-IFN will be administered .

  • Hepatitis B Vaccine

    Drug

    Hepatitis B vaccine will be administered.

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: AHB-137 (16 weeks) and Peg-IFNExperimental treatment 2 interventions
Group B: AHB-137 (24 weeks) and Peg-IFNExperimental treatment 2 interventions
Group C: AHB-137 and Hepatitis B vaccineExperimental treatment 2 interventions
Group D: AHB-137Experimental treatment 1 intervention
Group E: AHB-137 (24 weeks) and Peg-IFN(24 weeks)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
up to 72 weeks

Secondary outcomes

1

Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ .

Time frame
Up to 72 weeks
2

Detection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.

Time frame
Up to 72 weeks
3

Proportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period.

Time frame
Up to 48 weeks
4

Relapse rate after discontinuation of NAs therapy.

Time frame
Up to 72 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ausper Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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