Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients

  • STATUS
    Recruiting
  • End date
    Nov 30, 2029
  • participants needed
    5000
  • sponsor
    Third Affiliated Hospital, Sun Yat-Sen University
Updated on 21 April 2022

Summary

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. Guideline of European Association for the Study of the Liver(EASL)-2017 suggests that people with a family history of cirrhosis and liver cancer at this stage could be treated with antiviral therapy even if they did not meet the indications of antiviral therapy. According to Guidelines for the Prevention and Treatment of Chronic Hepatitis B (version 2019) of China, antiviral therapy is still recommended for some patients with inactive HBsAg carrier status who are HBV DNA positive and meet the treatment indications. Studies have shown that some patients in immune tolerance stage may enter the immune clearance stage and have hepatitis flare. Patients of inactive CHB have the potential to develop HBeAg-negative CHB, and studies of long-term follow-up in this population have indicated the risk of hepatocellular carcinoma. With the popularization of the concept of functional cure for chronic hepatitis B, more and more people with inactive CHB have a strong desire for treatment. In recent years, several studies have demonstrated that Pegylated-interferon therapy can achieve high functional cure rate in patients with inactive CHB.

The purpose of this study is to establish a national multi-center, prospective real world study to compare the efficacy of different antiviral treatment regimens for patients with inactive CHB and seek for the factors of functional cure.

Details
Condition Hepatitis B, Chronic
Treatment Peginterferon alfa-2b, Nucleoside Analogs, Nucleoside Analogs
Clinical Study IdentifierNCT05182463
SponsorThird Affiliated Hospital, Sun Yat-Sen University
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

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 α-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 < 3.5×109/L and/or platelet count < 80×109/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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