Health TrialsbyHealthPanel

Study of AHB-171 in Chronic Hepatitis B Participants

ConditionHepatitis B, Chronic (CHB)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAusper Biopharma Co., Ltd.

About this trial

The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to fully understand and sign the informed consent form (ICF).

Male or female participants, aged 18-65 years (inclusive).

Body mass index (BMI) meeting the predefined eligibility range.

Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening.

Disqualifiers

History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation.

Prior history of solid organ or hematopoietic stem cell transplantation.

History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk.

History or presence of hepatic decompensation at screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AHB-171 Injection

    Drug

    Subcutaneous injection

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: AHB-171 in Treatment CHBExperimental treatment 1 intervention
Group B: AHB-171 in Naïve CHBExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL)

Time frame
Up to 90 days

Secondary outcomes

1

Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ)

Time frame
Up to 90 days
2

Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit

Time frame
Up to 90 days
3

Proportion of participants with HBsAg decline from baseline of <0.5, ≥0.5, ≥1.0, ≥1.5, ≥2.0, ≥3.0 log₁₀ IU/mL at each visi

Time frame
Up to 90 days
4

Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit

Time frame
Up to 90 days

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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