A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia
Chronic HBV Infection
About this trial
This is an interventional treatment trial for Chronic HBV Infection
Eligibility Criteria
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).
Sites / Locations
- Beijing Ditan Hospital,Capital Medical University
- Beijing Friendship Hospital,Capital Medical University
- Beijing Youan Hospital,Capital Medical University
- Mengchao Hepatobiliary Hospital Of Fujian Medical University
- Nanfang Hospital of Southern Medical University
- The Sixth Peoples Hospital Of Zhengzhou
- The First Hospital of Jilin University
- Shandong Public Health Clinical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
NrtIs
HH-003+NrtIs
HH-003+NrtIs+PEG-IFN-α