Inactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A PegIFN α- 2b monotherapy, 180 μg/ week, 68 weeks of treatment, 24 weeks of follow-up after drug withdrawal |
Drug: PegIFN 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）
Other Names:
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| Active Comparator: Group B 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. |
Drug: PegIFN 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）
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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age 18 to 65 years;
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HBsAg seropositive status for more than 6 months prior to enrollment;
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never received treatment with any form of nucleos(t)ide analogues (NAs) or interferon before enrollment;
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Serum HBsAg ≤1500 IU/mL;
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HBeAg negative with or without HBeAb positive;
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Serum HBV DNA ≤2000IU/ml IU/mL;
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normal ALT levels;
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normal white blood cell and platelet counts;
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abdominal computed tomography or B-ultrasound showed no cirrhosis, splenomegaly or ascites.
Exclusion Criteria:
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Participants with other hepatotropic viruses or human immunodeficiency virus co-infection
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other chronic non-viral liver diseases or decompensated liver diseases
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tumours
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drug abuse
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severe psychiatric disease
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uncontrolled thyroid disease or diabetes
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pregnancy or lactation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Henan Provincial People's Hospital | Zhengzhou | Henan | China | 450000 |
Sponsors and Collaborators
- Henan Provincial People's Hospital
- Xiamen Amoytop Biotech Co., Ltd.
Investigators
- Study Chair: Jia Shang, Henan Provincial People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HenanPPHGRK