Chronic Hepatitis B
Conditions
Keywords
inactive hepatitis B virus carriers, HBsAg clearance, peginterferon alpha 2b, Intervention 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.
Interventions
DRUGPegIFN 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）
Sponsors
Xiamen Amoytop Biotech Co., Ltd.
Henan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| HBsAg clearance and seroconversion rate of PEG IFN based immunoadjuvant combined therapy | 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 |
Countries
China
Outcome results
None listed