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

NCT ID: NCT05451420

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2021-12-31

Brief 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

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

PegIFN α- 2b monotherapy, 180 μg/ week, 68 weeks of treatment, 24 weeks of follow-up after drug withdrawal

Group Type: EXPERIMENTAL

PegIFN α- 2b

Intervention Type: DRUG

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）

Group B

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.

Group Type: ACTIVE_COMPARATOR

PegIFN α- 2b

Intervention Type: DRUG

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）

Interventions

PegIFN α- 2b

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）

Intervention Type: DRUG

Other Intervention Names

pegbin ® 180μg，produced by Xiamen Tebao Bioengineering Co., Ltd.

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiamen Amoytop Biotech Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Shang

Role: STUDY_CHAIR

Henan Provincial People's Hospital

Locations

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37577817 (View on PubMed)

Other Identifiers

HenanPPHGRK

Identifier Type: -

Identifier Source: org_study_id