New combo therapy aims to cure hepatitis b in over half of patients
NCT ID NCT05769816
First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This phase 2 trial tests a new combination of an anti-PD-1 antibody (a type of immunotherapy) plus standard antiviral drugs in 120 adults with chronic hepatitis B. The goal is to achieve a functional cure, where the virus is no longer active and patients can stop medication. The study builds on earlier work that achieved cure in up to 50% of certain patients, and aims to improve that rate to over 50% overall.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anti-PD-1 antibody (a type of immunotherapy) and nucleos(t)ide analogues (antiviral drugs)
- What this could lead to
- If successful, this combination could help more than half of patients achieve a functional cure, meaning the virus is controlled without lifelong medication.
- What could go wrong
- This is a phase 2 trial with only 120 participants, so results are preliminary. The anti-PD-1 antibody may cause immune-related side effects, and the cure rate may not reach the hoped-for 50%.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 120 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 70 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\) From inclusion to 30 days after the last administration of the study drug, male subjects or female subjects of childbearing age are willing to voluntarily take effective contraceptive measures; * 3\) 18-70 years old. The weight of male subjects is not less than 45 kg, and the weight of female subjects 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. 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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