Can checkpoint inhibitors help the immune system clear hepatitis b?
NCT ID NCT07845058
First seen Sep 28, 2026 · Last updated Sep 29, 2026 · Updated 1 time
Summary
Researchers are testing a combination of an anti-PD-1/anti-PD-L1 antibody, pegylated interferon alfa, and nucleos(t)ide analogues in adults with chronic hepatitis B. The goal is to see whether this mix can help more people lose hepatitis B surface antigen, which doctors call a functional cure. The trial enrolls about 1,200 people aged 18 to 60, including those new to antivirals and those already taking them.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of an anti-PD-1/anti-PD-L1 antibody, pegylated interferon alfa, and nucleos(t)ide analogues
- What this could lead to
- If it works, this could raise the share of people who clear hepatitis B surface antigen, a marker some doctors treat as a functional cure. It may also point to a new way to wake up exhausted immune cells against the virus.
- What could go wrong
- This is a Phase 2 trial, so researchers do not yet know if the combination is safe or effective for chronic hepatitis B. Checkpoint inhibitors can cause immune-related side effects, and the trial may not reach its goal of clearing the virus in most participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 1,200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Sign the informed consent form before inclusion and be able to complete the study according to the study requirements; 2. 18-60 years old. 3. NAs-naive/NAs-experienced CHB patients. Exclusion Criteria: 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 liver fibrosis; 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 before enrollment (except that the malignant tumors have been completely relieved after treatment and patients have not received additional medical or surgical intervention within 3 years before screening); 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 (such as nausea, vomiting, or diarrhea) \>2 grades; 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\<90 × 10\^9/L, white blood cell count\<3.0 × 10\^9/L, neutrophil count\<1.3 × 10\^9/L, total serum bilirubin\>2 × upper limit of normal (ULN), albumin\<30 g/L, creatinine clearance ≤ 60 mL/min (calculated by CKD-EPI formula), or international normalized ratio of prothrombin time (INR)\>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. Subjects who are considered by the researcher to have other factors that are not suitable for the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The 2nd affiliated Hospital of Chongqing Medical University
RECRUITINGChongqing, Chongqing Municipality, 400010, China
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Other studies related to the condition(s) this trial covers.
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- Alcohol may leave a chemical fingerprint on DNA in hepatitis b
- Can a drug cocktail crack hepatitis B's surface antigen?
- Clearing hepatitis b may lift the weight of stigma, study asks
- Can immune checkpoint inhibitors crack hepatitis B's functional cure?