Chronic Hepatitis B study: Sintilimab/Envafolimab vs ETV/TDF/TAF
Official title A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (A)
ClinicalTrials.gov ID: NCT07852091
What this study is testing
What is Sintilimab/Envafolimab?
An investigational drug being studied for chronic hepatitis B. It is designed to block the PD-1/PD-L1 pathway to reverse T cell exhaustion.
Also referred to as Sintilimab (anti‑PD‑1), Envafolimab (anti‑PD‑L1).
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
- The trial wants to see if adding an immune‑boosting antibody to interferon can safely increase the rate of HBsAg loss, a marker of a functional cure, in patients already on antiviral drugs.
- Who it's for
- It is looking for adults who have chronic hepatitis B and have been treated with nucleos(t)ide analogues for at least 12 months.
- What's involved
- Participants will receive the antibody and interferon injections, attend regular clinic visits, and have blood tests to monitor safety and virus markers.
- Time commitment
- The study lasts about 48 weeks, with visits every 4–8 weeks for injections, blood draws, and health checks.
- 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 60
You may be able to join if
- Sign the informed consent form before inclusion and be able to complete the study according to the study requirements;
- 18-60 years old.
- NAs-naive/NAs-experienced CHB patients.
You likely can't join if
- 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;
- Use of inhibitors, inducers or substrates of CYP3A4 within 28 days before enrollment;
- Systematical use of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before enrollment, or vaccination of live...
- Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires anti-infection...
- Clinically significant acute and chronic liver disease not caused by HBV infection (judged by reseachers);
- Confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal...
See the full eligibility criteria
- Sign the informed consent form before inclusion and be able to complete the study according to the study requirements;
- 18-60 years old.
- NAs-naive/NAs-experienced CHB patients.
- 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;
- Use of inhibitors, inducers or substrates of CYP3A4 within 28 days before enrollment;
- 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;
- Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires anti-infection treatment when enrollment;
- Clinically significant acute and chronic liver disease not caused by HBV infection (judged by reseachers);
- 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 liver...
- 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...
- A history of pathological fracture or osteoporosis;
- 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...
- Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal and other systems;
- Major trauma or major surgery within 3 months before enrollment, or planned surgery during the study period;
- 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;
- Platelet count\ 2 × upper limit of normal (ULN), albumin\ 1.5 (unless receiving stable anticoagulant therapy);
- Hepatitis C virus (HCV) antibody (+), HIV antigen/antibody (+), or treponema pallidum antibody (+) and rapid plasma regain (RPR) test (+);
- A history of continuous alcohol abuse within 3 years before enrollment (average daily alcohol consumption exceeds 20 gram);
- A history of drug dependence or drug abuse within 1 year before enrollment;
- 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;
- Female in suckling period or pregnancy test (+) during screening;
- 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 is enrolling
- Chongqing, Chongqing Municipality, China
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but 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 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.