Anti‑PD‑1 plus antivirals and interferon to try for sustained HBsAg loss in chronic hepatitis B
Official title: A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)
Run by The Second Affiliated Hospital of Chongqing Medical University · NCT05769816 · Data updated 2026-11-12
This trial will try adding an anti‑PD‑1 antibody to standard nucleos(t)ide antivirals (with sequential interferon in some patients) to see if more adults with chronic hepatitis B can achieve sustained HBsAg loss.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | The Second Affiliated Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Status | Recruiting |
| Started | October 10, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT05769816 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with chronic hepatitis B who meet BMI and contraception requirements and who are either NA‑naive or NA‑experienced may be eligible.
✕Probably not a fit
Patients with recent use of immunosuppressants or certain CYP3A4 interacting drugs, known allergy to the study agents, or other exclusionary conditions are unlikely to be eligible and may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 trial tests a combination approach that adds an anti‑PD‑1 antibody to ongoing nucleos(t)ide analogue (NA) therapy and uses sequential interferon in some patients to pursue sustained HBsAg loss (functional cure). It enrolls adults 18–70 years old, including both NA‑naive and NA‑experienced patients, with standard BMI and contraception requirements. The design builds on a prior 'New Switch' program that increased HBsAg loss to about 15% overall and 30–50% in patients with lower baseline HBsAg by adding interferon after NA therapy. The study aims to see whether adding PD‑1 blockade can further raise durable HBsAg loss rates while monitoring safety.
Why it matters
Potential benefit: If successful, this combination approach could substantially increase the proportion of patients who achieve sustained HBsAg loss and lower long‑term liver disease risk.
How similar studies have gone: Previous sequential NA-to‑interferon 'New Switch' work increased HBsAg loss rates moderately, but adding PD‑1 blockade in chronic HBV is relatively novel and not yet proven effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
The 2nd affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China Recruiting
Study contacts
- Study coordinator: Dachuan Cai, MD
- Email: cqmucdc@cqmu.edu.cn
- Phone: +86 18323409779
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Combination therapy for functional cure in chronic hepatitis B
This phase 2 trial tests whether a sequence of anti-PD-1/PD-L1 antibodies with pegylated interferon and nucleos(t)ide analogues can achieve functional cure (HBsAg loss) in adults with chronic hepatitis B.
-
Combination of peg‑IFNα and an anti‑PD‑1 antibody plus antiviral therapy to try to cure chronic hepatitis B
This phase 2 test will try adding an anti‑PD‑1 antibody to peg‑IFNα and nucleos(t)ide therapy to see if it produces sustained HBsAg loss in adults with chronic hepatitis B.
-
Impact of functional cure on patient-reported outcomes in chronic hepatitis B
This study tests whether people with chronic hepatitis B who achieve a functional cure have better patient-reported outcomes compared to those not cured, relapse, or healthy controls.
-
Sequential combination therapy for functional cure of chronic hepatitis B
This trial tests a new two-drug approach to see if adding immunotherapy to ongoing HBV treatment can lead to loss of hepatitis B surface antigen in adults with chronic hepatitis B.
-
GST-HG131/GST-HG141 tablets vs placebo in chronic hepatitis B
A phase IIa trial tests GST-HG131 and GST-HG141 tablets against placebo to see if they are safe and help people with chronic hepatitis B.
-
AHB-137 injection in people with chronic hepatitis B
This study tests AHB-137 vs placebo in adults with chronic hepatitis B who have not yet received antiviral treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.