Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients
Hepatitis B, Chronic
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring inactive chronic hepatitis B, functional cure
Eligibility Criteria
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.
Sites / Locations
- Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Sequential Combination Group
Initial Combination Group
Whole-course Combination Group
Peginterferon Monotherapy Group
NAs Monotherapy Group
Oral nucleos(t)ide analogues (NAs) (Entecavir(ETV), Tenofovir disoproxil fumarate tablets(TDF) or Tenofovir Alafenamide Fumarate(TAF)) is used for 12-24 weeks, followed by combination therapy with peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks.
NAs combined with peginterferon are used for 12-24 weeks, followed by peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks.
NAs combined with peginterferon are used for a maximum course of 96 weeks. Follow-up period is 144 weeks.
Peginterferon is used for a maximum course of 96 weeks. Follow-up period is 144 weeks.
NAs is used for a maximum course of 96 weeks. Follow-up period is 144 weeks.