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NCT Number: NCT05451420

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

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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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PegIFN α- 2b

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）

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

Primary outcomes

  1. HBsAg clearance at the end of 68 weeks of treatment

    Time frame: 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

  1. HBsAg level and the decreasing extent of HBsAg level

    Time frame: 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

  2. HBsAg seroconversion rate

    Time frame: 68 weeks of treatment

    To assessment the HBsAg seroconversion rate in different treatment groups

Other outcomes

  1. HBsAg clearance and seroconversion rate of PEG IFN based immunoadjuvant combined therapy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Collaborators

  • Xiamen Amoytop Biotech Co., Ltd.

Registry information

Official study title

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)

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jul 11, 2022
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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