Clinical trial NCT05451420: Inactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hepatitis B
Keywords: inactive hepatitis B virus carriers
HBsAg clearance
peginterferon alpha 2b
Intervention treatment
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Xiamen Amoytop Biotech Co., Ltd.
First posted: 2022-07-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HBsAg clearance at the end of 68 weeks of treatment
timeFrame: 68 weeks of treatment
Secondary outcomes:
measure: HBsAg level and the decreasing extent of HBsAg level
timeFrame: baseline，12 weeks, 24 weeks, 44 weeks，56 weeks， 68weeks，80 weeks，92weeks of treatment
measure: HBsAg seroconversion rate
timeFrame: 68 weeks of treatment
Other outcomes:
measure: HBsAg clearance and seroconversion rate of PEG IFN based immunoadjuvant combined therapy
timeFrame: baseline，12 weeks, 24 weeks, 44 weeks，56 weeks， 68weeks，80 weeks，92weeks of treatment
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: Jia Shang
role: STUDY_CHAIR
References: