A Study of RBD1016 in CHB Participants (NCT05961098) | Clinical Trial Compass
CompletedPhase 2
A Study of RBD1016 in CHB Participants
China, Sweden48 participantsStarted 2023-10-11
Plain-language summary
This study is a multi-center, randomized, double-blind, placebo-controlled clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection on NAs background treatment in CHB participants.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
. HBV DNA level \<100 IU/mL at screening;
. HBsAg level ≥50 IU/mL at screening;
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.