A 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
- Registration Number
- NCT05839639
- Lead Sponsor
- Huahui Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NrtIs NrtIs - HH-003 HH-003 - HH-003+NrtIs HH-003+NrtIs -
- Primary Outcome Measures
Name Time Method Changes from baseline in serum HBsAg levels From treatment start to Week 24 Proportion of participants achieving sustained viral response From baseline to Week 24
- Secondary Outcome Measures
Name Time Method 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 Proportion of participants with normal ALT levels From treatment start to Week 48 Duration of sustained viral response From treatment start to Week 48
Trial Locations
- Locations (1)
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University🇨🇳Guangzhou, Guangdong, China