Sequential combination therapy for functional cure of chronic hepatitis B

Is this trial a fit for you?

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 interventional study evaluates a sequential combination strategy using pembrolizumab-like or similar PD-1/PD-L1 inhibitors with existing antiviral therapy to enhance HBsAg loss in chronic hepatitis B patients. Eligible participants include adults 18-60 who are either NAs-naive or -experienced. The study aims to improve functional cure rates beyond current therapies by integrating immune modulation with standard antiviral treatment. Primary endpoints likely focus on incidence of sustained HBsAg loss and safety signals, with secondary assessments of virologic response and liver function over the treatment period. The trial is led by The Second Affiliated Hospital of Chongqing Medical University with several regional collaborators in China.

Why it matters

Who can join: the full rules

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

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.

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  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.

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• GST-HG131/GST-HG141 tablets vs placebo in chronic hepatitis B

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• AHB-137 injection in people with chronic hepatitis B

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• ASC22 plus pegylated interferon alfa to try to achieve a functional cure for chronic hepatitis B

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  Recruiting Phase 4 The Second Affiliated Hospital of Chongqing Medical University · Chongqing, Chongqing Municipality · NCT07573943

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.