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
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
Treatments tested in this trial
- AHB-137
- Peg-IFN
- Hepatitis B Vaccine
Treatment groups
200 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov