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

Completed 33 enrolled Henan Provincial People's Hospital Xiamen Amoytop Biotech Co., Ltd. · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

A single center, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control period (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

Timeline

Start: 2017-12-01
Primary completion: 2020-06-30
Completion: 2021-12-31

Outcome

Missed primary endpoint

paper There was no statistically significant difference in HBsAg loss rate between groups A and B ( P > 0.05). PMID 37577817 ↗

Publications

Ning H, Li K, Peng Z, Jin H, Zhao H, Shang J. The efficacy and safety of pegylated interferon alpha-2b-based immunotherapy for inactive hepatitis B surface antigen carriers. Eur J Gastroenterol Hepatol. 2023 Oct 1;35(10):1216-1223. doi: 10.1097/MEG.0000000000002627. Epub 2023 Aug 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GM-CSF	Protein / enzyme biologic	100 ug	Subcutaneous
Subject	Hepatitis B vaccine	Vaccine	60 ug	Subcutaneous
Subject	Peg-IFNα-2b	Protein / enzyme biologic	180 ug	—