Health TrialsbyHealthPanel

A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)

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

About this trial

This is an open-label, multicenter, Phase 2 study designed to evaluate the efficacy and safety of AHB-137 injection in participants with chronic hepatitis B (CHB) with low hepatitis B surface antigen (HBsAg) levels.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in the study and sign the informed consent form;

18-65 years of age (including boundary values) ;

Body mass index met the requirements;

Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months;

Disqualifiers

Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection;

Associated liver disease;

Any serious infection other than CHB infection requires intravenous anti-infective therapy;

HCV RNA positive, HIV antibody positive, syphilis positive;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AHB-137

    Drug

    AHB-137 will be injected

  • NA therapy

    Drug

    NA will be usede.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Part A: AHB-137 With NA TherapyExperimental treatment 2 interventions
Group B: Part B: AHB-137 with NA TherapyExperimental treatment 2 interventions
Group C: Part B: AHB-137 Without NA TherapyExperimental treatment 1 intervention

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
At the 24th week after all treatment for CHB was discontinued

Secondary outcomes

1

Proportion of participants with persistent HBV DNA < LLOQ .

Time frame
During the 24-week period after discontinuation of all CHB treatment
2

Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ).

Time frame
Up to 60 weeks
3

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

Time frame
Up to 60 weeks
4

Relapse rate and time after discontinuation of NAs therapy.

Time frame
Up to 60 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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