Antiviral therapy for chronic hepatitis B with nonalcoholic fatty liver disease

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 study evaluates the efficacy and safety of peg-interferon α-based antiviral therapy in patients with chronic hepatitis B complicated by nonalcoholic fatty liver disease. It involves 1500 patients who are divided into a test group receiving peg-interferon therapy and a control group receiving nucleos(t)ide analogues. The primary goal is to assess HBsAg clearance at 48 weeks, with additional follow-up points to gather comprehensive data on treatment outcomes and adverse events. The study is designed to provide real-world evidence on the effectiveness of this treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age of 18-60 years old, male or female (including 18 and 60 years old);
2. meet the diagnostic criteria for chronic hepatitis B in the Guidelines for the prevention and treatment of chronic hepatitis B (2022 edition), and meet the imaging diagnostic criteria for fatty liver in the guidelines for the prevention and treatment of non-alcoholic fatty liver disease (2018 Update edition).
3. serum HBsAg positive \>6 months;
4. NAs treatment: baseline HBsAg≤1500 IU/ml, HBeAg negative, HBV DNA negative (not detected);
5. IHC initial treatment: baseline HBsAg\<1000 IU/ml, HBeAg negative, HBV DNA negative (undetectable), ALT and AST persistently normal (ULN: \<50 IU/L in men, \<40 IU/L in women);
6. a negative serum pregnancy test within 24 hours before the first dose (for women of reproductive age);
7. willing to receive treatment and signed informed consent.

Exclusion Criteria:

1. co-infection with active hepatitis A, C, D, E and/or HIV; Or combined with drug-induced liver injury, inherited metabolic liver disease, autoimmune hepatitis, alcoholic liver disease;
2. Liver tumor was detected by liver imaging at the time of screening;
3. patients diagnosed with hepatitis B cirrhosis, that is, those with liver biopsy pathology consistent with liver cirrhosis, or with two or more of the following five criteria, excluding non-cirrhotic portal hypertension: ① imaging examination showed signs of liver cirrhosis and/or portal hypertension; ② Esophagogastric varices were found by endoscopy; ③ Liver stiffness was consistent with cirrhosis; ④ Blood biochemical examination showed decreased albumin level (\< 35 g/L) and/or prolonged prothrombin time (prolonged \> 3 seconds compared with the control); ⑤ Blood routine examination showed platelet count \< 100×109/L;
4. pregnant or lactating women or those who plan to become pregnant and do not want to use contraception during the study period;
5. neutrophil count \<1.5×109/L or platelet count \<90×109/L. Patients with creatinine higher than 1.5 times the upper limit of normal;
6. The patients and their close relatives (parents, siblings, etc.) had a history of severe mental illness, especially depression. Severe psychosis is defined as severe depression or psychosis, suicide attempt, hospitalization due to psychosis, or a period of incapacitation due to psychosis;
7. patients with a history of immune-mediated diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies;
8. patients with serious diseases of heart, lung, kidney, brain, blood and other important organs, and patients with other malignant tumors;
9. history of severe epilepsy or current use of antiepileptic drugs. Control of unstable diabetes, hypertension, thyroid disease, etc. A history of severe retinopathy or other evidence of retinopathy;
10. any history of organ transplantation and existing functional graft (except corneal or hair transplantation);
11. patients who are allergic to interferon and its drug components, and who are not suitable for interferon according to the investigator's judgment;
12. Patients deemed by the investigator to be ineligible for the study.

Where it's running

• Ningbo No.2 Hospital
  Ningbo, China Recruiting
• Ruian People's Hospital
  Rui’an, China Recruiting
• The Second Affiliated Hospital of Wenzhou Medical University
  Wenzhou, China Recruiting
• Wenzhou People's Hospital
  Wenzhou, China Recruiting
• Yueqing People's Hospital
  Yueqing, China Recruiting

Study contacts

• Study coordinator: Yongping Chen, Professor
• Email: 13505777281@163.com
• Phone: 13505777281

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• 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.

  Recruiting Phase 2 The Second Affiliated Hospital of Chongqing Medical University · Chongqing, Chongqing Municipality · NCT07845058

• 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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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.