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

Henan Provincial People's Hospital33 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

PegIFN α- 2bDRUG

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）

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Outcomes

Primary Outcomes

HBsAg clearance at the end of 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.

Time frame: 68 weeks of treatment

Secondary Outcomes

HBsAg level and the decreasing extent of HBsAg level

To assessment the decreasing level and difference of HBsAg levels in different treatment groups

Time frame: baseline，12 weeks, 24 weeks, 44 weeks，56 weeks， 68weeks，80 weeks，92weeks of treatment

HBsAg seroconversion rate

To assessment the HBsAg seroconversion rate in different treatment groups

Time frame: 68 weeks of treatment

Data from ClinicalTrials.gov

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