Status:
RECRUITING
Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 perina...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2029
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT05182463
Start Date
January 8 2022
End Date
November 30 2029
Last Update
May 1 2025
Active Locations (1)
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1
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630