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New treatment option for Chronic Hepatitis b
Official title A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (B)
ClinicalTrials.gov ID: NCT05771402
What this study is testing
What is Anti-PD-1 antibody?
Anti-PD-1 antibody is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic hepatitis b.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 1) Sign the informed consent form before inclusion and be able to complete the study according to the study requirements;
- 2) From inclusion to 30 days after the last administration of the study drug, male people or female people of childbearing age are willing to...
- 3) 18-70 years old. The weight of male people is not less than 45 kg, and the weight of female people is not less than 40 kg. Body mass index (BMI)...
- 4) NAs-naive/NAs-experienced CHB patients.
You likely can't join if
- 1) A history of allergy, or who are suspected by the researcher to be allergic to the active ingredient of the drug under study or its excipients;
- 2) Use of inhibitors, inducers or substrates of CYP3A4 within 28 days before enrollment;
- 3) Systematical use of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before enrollment, or vaccination of live...
- 4) Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires...
- 5) Clinically significant acute and chronic liver disease not caused by HBV infection (judged by reseachers);
- 6) Confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from...
See the full eligibility criteria
- 1) Sign the informed consent form before inclusion and be able to complete the study according to the study requirements;
- 2) From inclusion to 30 days after the last administration of the study drug, male people or female people of childbearing age are willing to voluntarily take effective contraceptive measures;
- 3) 18-70 years old. The weight of male people is not less than 45 kg, and the weight of female people is not less than 40 kg. Body mass index (BMI) is within the range of 18-32 kg/m\^2;
- 4) NAs-naive/NAs-experienced CHB patients.
- 1) A history of allergy, or who are suspected by the researcher to be allergic to the active ingredient of the drug under study or its excipients;
- 2) Use of inhibitors, inducers or substrates of CYP3A4 within 28 days before enrollment;
- 3) Systematical use of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before enrollment, or vaccination of live attenuated vaccine within 1 month before enrollment;
- 4) Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires anti-infection treatment when enrollment;
- 5) Clinically significant acute and chronic liver disease not caused by HBV infection (judged by reseachers);
- 6) Confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal varices, splenomegaly, ascites, etc, or evidence of progressive...
- 7) Primary liver cancer, or alpha-fetoprotein (AFP) is greater than 50 ug/L or imaging suggests the possibility of malignant liver lesions, or other malignant tumors or a history of other malignant tumors within 5 years...
- 8) A history of pathological fracture or osteoporosis;
- 9) Gastrointestinal dysfunction or gastrointestinal diseases that might affect the absorption of oral drugs, such as severe gastric ulcer, erosive gastritis, partial gastrectomy, and persistent gastrointestinal symptoms...
- 10) Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal and other systems;
- 11) Major trauma or major surgery within 3 months before enrollment, or planned surgery during the study period;
- 12) Blood donation/loss ≥ 400 mL within 3 months before enrollment, or given a blood transfusion within 3 months before enrollment, or blood donation/loss ≥ 200 mL within 1 month before enrollment;
- 13) Platelet count\ 2 × upper limit of normal (ULN), albumin\ 1.5 (unless receiving stable anticoagulant therapy);
- 14) Hepatitis C virus (HCV) antibody (+), HIV antigen/antibody (+), or treponema pallidum antibody (+) and rapid plasma regain (RPR) test (+);
- 15) A history of continuous alcohol abuse within 3 years before enrollment (average daily alcohol consumption exceeds 20 gram);
- 16) A history of drug dependence or drug abuse within 1 year before enrollment;
- 17) Those who have participated in clinical trials of other investigational drugs or medical devices and taken investigational drugs or used medical devices within 3 months before enrollment;
- 18) Female in suckling period or pregnancy test (+) during screening;
- 19) people who are considered by the researcher to have other factors that are not suitable for the study
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.