Inactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy

• Status: Completed
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A single center, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control period (i.e. HBsAg positive, HBeAg negative, normal ALT, HBsAg ≤ 1500iu/ml, HBV DNA ≤ 2000iu/ml) to enter the study, and to compare the feasibility, effectiveness and safety of pegylate combined with Granulocyte-macrophage colony stimulating factor, high-dose hepatitis B vaccine and pegylate monotherapy in the treatment of patients with chronic hepatitis B in the immune control period

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Provincial People's Hospital
• Collaborator: Xiamen Amoytop Biotech Co., Ltd.

Criteria

Inclusion Criteria:

• age 18 to 65 years;

• HBsAg seropositive status for more than 6 months prior to enrollment;

• never received treatment with any form of nucleos(t)ide analogues (NAs) or interferon before enrollment;

• Serum HBsAg ≤1500 IU/mL;

• HBeAg negative with or without HBeAb positive;

• Serum HBV DNA ≤2000IU/ml IU/mL;

• normal ALT levels;

• normal white blood cell and platelet counts;

• abdominal computed tomography or B-ultrasound showed no cirrhosis, splenomegaly or ascites.

Exclusion Criteria:

• Participants with other hepatotropic viruses or human immunodeficiency virus co-infection

• other chronic non-viral liver diseases or decompensated liver diseases

• tumours

• drug abuse

• severe psychiatric disease

• uncontrolled thyroid disease or diabetes

• pregnancy or lactation