NCT05734807
Completed
Phase 2
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
Huahui Health8 sites in 1 country74 target enrollmentStarted: July 20, 2022Last updated:
ConditionsChronic HBV Infection
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Huahui Health
- Enrollment
- 74
- Locations
- 8
- Primary Endpoint
- Percentage of subjects with HBV DNA negativation
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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).
Arms & Interventions
NrtIs
Active Comparator
Intervention: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs) (Drug)
HH-003+NrtIs
Experimental
Intervention: HH-003 and NrtIs (Drug)
HH-003+NrtIs+PEG-IFN-α
Experimental
Intervention: HH-003, NrtIs and PEG-IFN-α (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Duration of MVR(From treatment start up to 48 weeks)
- Percentage of subjects achieving maintained virologic response (MVR)(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)
- Percentage of subjects with ALT normalization(From treatment start up to 48 weeks)
Investigators
Study Sites (8)
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