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Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease(OCEAN PROJECT)

RecruitingPhase 4Ages 18 Years - 60 YearsAllFirst Affiliated Hospital of Wenzhou Medical Univ…
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In plain words

What the trial is, and whether it could suit you

This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease. A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group(500 patients receiving NAs monotherapy) according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly. The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of trea

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📋 Eligibility rules (as published)
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.
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What it tests

  • Peg-Interferon α
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Where

5 sites
Ningbo No.2 Hospital
Ningbo, China
Ruian People's Hospital
Rui’an, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Wenzhou People's Hospital
Wenzhou, China
Yueqing People's Hospital
Yueqing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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