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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
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.
Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Percentage of subjects with HBV DNA negativation
Time frame: Week 24
Changes from baseline in serum HBsAg
Time frame: From treatment start up to Week 48
Percentage of subjects achieving maintained virologic response (MVR)
Time frame: From treatment start up to 48 weeks
Duration of MVR
Time frame: From treatment start up to 48 weeks
Percentage of subjects with ALT normalization
Time frame: From treatment start up to 48 weeks
Changes from baseline in serum HBeAg in subjects with positive HBeAg
Time frame: From treatment start up to 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, Fujian, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Sixth Peoples Hospital Of Zhengzhou
Zhengzhou, Henan, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shandong Public Health Clinical Center
Jinan, Shandong, China