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Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients

RecruitingPhase 4Ages 18 Years - 60 YearsAllThird Affiliated Hospital, Sun Yat-Sen University
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In plain words

What the trial is, and whether it could suit you

There are about 400 million chronic hepatitis B virus (HBV) infection patients worldwide, posing a serious threat to global public health security. In China, HBV infection occured mainly in the perinatal period or infants, and about 10% of patients in the immune tolerance stage spontaneously transit to the immune clearance stage every year and become HBeAg-negative chronic HBV infection, resulting in a significant increase in the number of inactive chronic hepatitis B (CHB) patients. In recent years, different guidelines have not reached consensus on the need to initiate antiviral therapy for inactive CHB patients: In the guidelines of Asian Pacific Association for The Study of Liver(APASL)-2015 and American Association for the Study of Liver Diseases(AASLD)-2018, antiviral therapy is generally not recommended for this group of patients, and regular outpatient follow-up is recommended.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 18-60, no gender limitation * HBsAg is positive for more than 6 months * Hepatitis B e antigen(HBeAg) is negative and anti-HBe is positive * Serum HBV DNA is less than 2000 IU/mL * Alanine aminotransferase(ALT) and/or Aspartate aminotransferase(AST) is normal * No antiviral durg (including nucleos(t)ide analogue and interferon) was used before enrollment * Good compliance and voluntarily signed informed consent Exclusion Criteria: * Allergic to pegylated interferon ฮฑ-2b * Any indication of liver cirrhosis * Coinfection with hepatitis A virus(HAV), hepatitis C virus(HCV), hepatitis D virus(HDV), hepatitis E virus(HEV) or human immunodeficiency virus(HIV) * Combined with other liver diseases (including drug-related, alcoholic, autoimmune, genetic metabolic liver diseases, etc.) * There are serious lesions in the important organs, such as heart, lung, kidney, brain and fundus * Patients with autoimmune diseases, unstable diabetes or thyroid diseases(hyperthyroidism or hypothyroidism) * Confirmed or suspected liver cancer or other malignant tumors * Patients after or preparing for organ transplantation * Peripheral blood white blood cell count \< 3.5ร—109/L and/or platelet count \< 80ร—109/L * Under immunosuppressant treatment * Pregnant or planned pregnancy in a short term or lactation patients * Alcohol abuse (average alcohol intake is more than 40 g/d in males or 20g/d in women) or drug addicts * Present or past history of mental or psychological diseases * Other conditions that the investigators deem inappropriate for the study.
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What it tests

  • Peginterferon Alfa-2B
  • Nucleoside Analogs
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Where

1 site
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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