Chronic HBV Infection
Conditions
Brief summary
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.
Interventions
DRUGNucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)
Subjects will receive NrtIs therapy for 24 weeks.
DRUGHH-003 and NrtIs
Subjects will receive HH-003 20 mg/kg intravenously Q2W and NrtIs therapy for 24 weeks.
DRUGHH-003, NrtIs and PEG-IFN-α
Subjects will receive HH-003 20 mg/kg intravenously Q2W, NrtIs therapy and PEG-IFN-α 180μg SC QW for 24 weeks.
Sponsors
Huahui Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent form; * Male or female aged from 18 to 60 years (inclusively); * 18 kg/m\^2≤BMI≤30 kg/m\^2, body weight≥50 kg for men and ≥45 kg for women; * Subjects who have chronic HBV infection greater than or equal to 6 months at screening; * 10 IU/mL≤HBsAg≤3000 IU/mL; HBV DNA≤2000 IU/mL; ALT≤3×ULN; * Subjects who have been on nucleoside reverse transcriptase inhibitors therapy for more than 1 year prior to screening.
Exclusion criteria
* Females who are pregnant or lactating at screening; * History of alcoholic liver disease, moderate fatty liver, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection; * History of cirrhosis at any time prior to or at time of screening, or having progressive liver fibrosis at screening ; * History or evidence of hepatocellular carcinoma at any time prior to or at time of screening; * Exclusionary laboratory results at screening: total bilirubin \>2xULN or direct bilirubin \>1.5xULN，hemoglobin \<120 g/L for males or \<110 g/L ro females，platelets count\<100,000/mm\^3 (100×10\^9/L), and absolute neutrophils count \<1,500/mm\^3 (1.5×10\^9/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with HBV DNA negativation | Week 24 |
| Changes from baseline in serum HBsAg | From treatment start up to Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving maintained virologic response (MVR) | From treatment start up to 48 weeks |
| Duration of MVR | From treatment start up to 48 weeks |
| Percentage of subjects with ALT normalization | From treatment start up to 48 weeks |
| Changes from baseline in serum HBeAg in subjects with positive HBeAg | From treatment start up to 48 weeks |
Countries
China
Outcome results
None listed