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

Not Applicable

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: PegIFN α- 2b

• Registration Number: NCT05451420
• Lead Sponsor: Henan Provincial People's Hospital

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.

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2020-06-30
• Study Completion: 2021-12-31
• Status Verified: 2022-06
• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-11
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	PegIFN α- 2b	PegIFN α- 2b monotherapy, 180 μg/ week, 68 weeks of treatment, 24 weeks of follow-up after drug withdrawal
Group B	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China