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

NCT05451420 — Not applicable, Completed, 33 participants, Henan Provincial People's Hospital

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The Efficacy and Safety of Inactive Hepatitis B Surface Antigen (HBsAg) Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy(HBsAg Positive, HBeAg Negative, ALT Normal, HBsAg ≤ 1500IU/ml, HBV DNA ≤ 2000IU/ml)

Registry	NCT05451420
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	33 (Actual)
Sponsor	Henan Provincial People's Hospital (Other); collaborators: Xiamen Amoytop Biotech Co., Ltd.
Conditions	Chronic Hepatitis B
Interventions	PegIFN α- 2b (Drug)
Dates	start 2017-12-01, primary completion 2020-06-30, completion 2021-12-31, first posted 2022-07-11, last updated 2022-07-13
Locations	1 site in China

-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

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+Detailed description

Explore the efficacy, safety and related influencing factors of intervention therapy based on PegIFN α- 2b in inactive hepatis B surface antigen (HBsAg) carriers (IHCs), and compare pegifn α- 2b combined with granulocyte macrophage stimulating factor (GM-CSF), high-dose hepatitis B vaccine and pegifn α- 2B feasibility, efficacy and safety of monotherapy for IHCs.The IHCs patients were randomly divided into two groups (group A: pegifn α- 2b single drug group, group B: pegifn α- 2b combined with GM-CSF and high-dose hepatitis B vaccine group). To start applying pegifn α- 2B was the baseline, treatment for 68 weeks, followed up for 24 weeks after drug withdrawal. Patients in group B used GM-CSF and vaccine introduction for 16 weeks before baseline.The HBsAg clearance rate and related influencing factors of the two groups at 68 weeks were analyzed.

+Arms and interventions

Arm	Type	Interventions	Description
Group A	Experimental	Drug: PegIFN α- 2b	PegIFN α- 2b monotherapy, 180 μg/ week, 68 weeks of treatment, 24 weeks of follow-up after drug withdrawal
Group B	Active comparator	Drug: PegIFN α- 2b	Patients had a lead-in period of 16 weeks before baseline, pegifn α- 2b single drug treatment for 24 weeks, 4 weeks after drug withdrawal, 16 weeks of introduction period, pegifn α- 2b was followed up for 24 weeks. The plan of the induction period is as follows: 1) from the first day of the induction period, GM-CSF is injected subcutaneously ® one hundred μg/ piece, produced by Xiamen Tebao Bioengineering Co., Ltd.), 100 μg/ day, 5 consecutive days, one cycle every 4 weeks, 4 consecutive cycles. 2) On the third day of the induction period, recombinant hepatitis B vaccine (Saccharomyces cerevisiae) (1.0ml/HBsAg 60 per dose) was injected subcutaneously μg. Shenzhen Kangtai Biological Products Co., Ltd.), 60 μ g. Once every 4 weeks for 4 consecutive cycles, the course of treatment was 68 weeks, and the patients were followed up for 24 weeks.

PegIFN α- 2b (Drug), also known as pegbin ® 180μg，produced by Xiamen Tebao Bioengineering Co., Ltd.: Adjuvant immunotherapy with GM-CSF and Hepatitis B vaccine ；GM-CSF（100 μg/ piece, produced by Xiamen Tebao Bioengineering Co., Ltd）；Hepatitis B vaccine（Each 1.0ml/HBsAg60 μ g. Shenzhen Kangtai Biological Products Co., Ltd）

+Outcome measures

Primary outcomes

HBsAg clearance at the end of 68 weeks of treatment [68 weeks of treatment]: To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 48 week treatment, compared with control group.

Secondary outcomes

HBsAg level and the decreasing extent of HBsAg level [baseline，12 weeks, 24 weeks, 44 weeks，56 weeks， 68weeks，80 weeks，92weeks of treatment]: To assessment the decreasing level and difference of HBsAg levels in different treatment groups
HBsAg seroconversion rate [68 weeks of treatment]: To assessment the HBsAg seroconversion rate in different treatment groups

Other outcomes

HBsAg clearance and seroconversion rate of PEG IFN based immunoadjuvant combined therapy [baseline，12 weeks, 24 weeks, 44 weeks，56 weeks， 68weeks，80 weeks，92weeks of treatment]: To assessment the HBsAg clearance and seroconversion rate of immunoadjuvant combined therapy on 68 weeks' curative effect

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Henan Provincial People's Hospital	Zhengzhou, Henan	China

+Publications

Results publication: 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. PMID 37577817

+Investigators

Jia Shang, Study chair, Henan Provincial People's Hospital