NCT05839639
Completed
Phase 2
A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors
Huahui Health1 site in 1 country73 target enrollmentStarted: October 9, 2021Last updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Huahui Health
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Changes from baseline in serum HBsAg levels
Overview
Brief Summary
This is a multicenter, randomized, controlled Phase IIa study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the antiviral activity and safety in subjects with with HBeAg-negative Chronic Hepatitis B treated with nucleos(t)ide reverse transcriptase inhibitors.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent form;
- •Male or female aged from 18 to 65years (inclusively);
- •18 kg/m\^2≤BMI≤32 kg/m\^2, body weight≥45 kg for men and ≥40 kg for women;
- •At screening, etiological, clinical, or pathological evidence indicates chronic hepatitis B virus infection for at least 6 months; and negative HBeAg for more than 6 months; 10 IU/mL≤HBsAg≤3000 IU/mL; HBV DNA≤20 IU/mL; ALT≤1×ULN;
- •Participants who have been on the treatment of nucleos(t)ide reverse transcriptase inhibitors (limited to entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\], or tenofovir alafenamide fumarate \[TAF\]) for at least 3 years (as judged by the investigator) at screening.
Exclusion Criteria
- •Females who are pregnant or lactating at screening;
- •History of alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection;
- •History or presence of progressive liver fibrosis or cirrhosis, including but not limited to liver stiffness measurement \[LSM\] ≥ 9 kPa at screening, progressive liver fibrosis or cirrhosis (e.g., S ≥ 3 in GS score or METAVIR ≥ F3) by liver histopathology examination, according to the Consensus on the diagnosis and therapy of hepatic fibrosis \[2019\]; or the presence of ascites, hepatic encephalopathy, upper gastrointestinal bleeding, or esophageal and gastric varices.
- •History or presence of hepatocellular carcinoma, or alpha-fetoprotein (AFP) ≥ 50 ng/mL at screening; or suspicion of hepatocellular carcinoma indicated by liver ultrasound, CT, or MRI.
- •Use of antiviral therapy with interferon within 1 year prior to screening
- •Any of the following lab test 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), Serum albumin \< 35 g/L; international normalized ratio (INR) of prothrombin time \> 1.3; or estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2.
Arms & Interventions
HH-003+NrtIs
Experimental
Intervention: HH-003+NrtIs (Drug)
NrtIs
Active Comparator
Intervention: NrtIs (Drug)
HH-003
Experimental
Intervention: HH-003 (Drug)
Outcomes
Primary Outcomes
Changes from baseline in serum HBsAg levels
Time Frame: From treatment start to Week 24
Proportion of participants achieving sustained viral response
Time Frame: From baseline to Week 24
Secondary Outcomes
- Proportion of participants with undetectable HBV DNA in those with positive HBV DNA at baseline(From treatment start to Week 24)
- Proportion of participants achieving sustained viral response(From baseline to Week 48)
- Changes from baseline in serum HBsAg levels(From treatment start up to Week 48)
- Proportion of participants with HBV pgRNA negativation in those with positive HBV pgRNA at baseline(From baseline to Week 24)
- Duration of sustained viral response(From treatment start to Week 48)
- Proportion of participants with normal ALT levels(From treatment start to Week 48)
Investigators
Study Sites (1)
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