Back to resultsA Study of RBD1016 in CHB Participants
Chronic Hepatitis b
About this trial
This is an interventional treatment trial for Chronic Hepatitis b
Eligibility Criteria
Inclusion Criteria: Willing and able to give written informed consent for study participation; Male or female participants aged 18-65 years; Body mass index (BMI) within the range of 18-34 kilograms/square meter (kg/m2); Documented history of chronic hepatitis B virus (HBV) infection, by positive HBsAg and/or HBV DNA tests ≥ 6 months before screening; HBeAg positive or negative at screening; On a stable regimen (≥ 12 months before screening) of any approved first-line oral NAs; Serum alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal (ULN); Liver transient elastography (FibroScan) results within 12 months before screening or at screening showing that the liver stiffness measurement (LSM) level is less than 9 kPa; or with liver biopsy within 24 months before screening showing that the Metavir score is F0-F2. Exclusion Criteria: Diagnosed with other liver diseases other than hepatitis B; History of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening; History of organ transplantation or previous or concurrent with hepatocellular carcinoma (HCC), or imaging findings suggesting a possibility of malignant liver lesions; Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E; Laboratory results at screening as follows: serum alpha-fetoprotein (AFP) >50 μg/L; serum albumin concentration <3.0 g/dL; international normalized ratio (INR) >1.5; platelet count <90×10^9/L; serum direct bilirubin (DB) >2×ULN; serum creatinine concentration >1.5×ULN or creatinine clearance <60 mL/min (according to the Cockcroft-Gault equation); or any clinically significant laboratory outliers that the investigator believes may interfere with the interpretation of the efficacy and safety data in this study; Those who the investigator believes are not suitable to participate in the study due to other factors. Additional exclusion criteria for Part B: Participants who are judged not to be suitable for IFN treatment for any reason; History of IFN treatment within 12 months prior to screening; Other situations that the investigator believes are not suitable to participate in Part B.
Sites / Locations
- Karolinska University HospitalRecruiting
- Clinical Trial Consultants AB
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
RBD1016/placebo 100 mg Q4W group
RBD1016/placebo 200 mg Q4W group
RBD1016/placebo 200 mg Q12W group
RBD1016+PegIFN-α 200 mg Q4W group
Participants in the 100 mg Q4W dose group will receive corresponding doses of RBD1016 injection or placebo by subcutaneous injection on D1, D29, D57, and D85.
Participants in the 200 mg Q4W dose group will receive corresponding doses of RBD1016 injection or placebo by subcutaneous injection on D1, D29, D57, and D85.
Participants in the 200 mg Q12W dose group will receive corresponding doses of RBD1016 injection or placebo by subcutaneous injection on D1, and D85.
Participants in the 200 mg Q4W dose group will receive corresponding doses of RBD1016 injection by subcutaneous injection on D1, D29, D57, and D85, and also receive 180 µg PegIFN-α subcutaneously every week for 48 weeks
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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