Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)
DrugSubjects will receive NrtIs therapy for 24 weeks.
NCT Number: NCT05734807
This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Phase 2
Beijing Ditan Hospital,Capital Medical University, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive NrtIs therapy for 24 weeks.
Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.
Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks.
Time frame: Week 24
Time frame: From treatment start up to Week 48
Time frame: From treatment start up to 48 weeks
Time frame: From treatment start up to 48 weeks
Time frame: From treatment start up to 48 weeks
Time frame: From treatment start up to 48 weeks
Huahui Health
Industry
A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 in Nucleos(t)Ide Analogues-treated Chronic Hepatitis B Subjects With Low-Level Viremia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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