Back to resultsInactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PegIFN α- 2b
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring inactive hepatitis B virus carriers, HBsAg clearance, peginterferon alpha 2b, Intervention treatment
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
Sites / Locations
- Henan Provincial People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
PegIFN α- 2b monotherapy, 180 μg/ week, 68 weeks of treatment, 24 weeks of follow-up after drug withdrawal
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
HBsAg level and the decreasing extent of HBsAg level
To assessment the decreasing level and difference of HBsAg levels in different treatment groups
HBsAg seroconversion rate
To assessment the HBsAg seroconversion rate in different treatment groups
Full Information
NCT ID
NCT05451420
First Posted
June 23, 2022
Last Updated
July 11, 2022
Sponsor
Henan Provincial People's Hospital
Collaborators
Xiamen Amoytop Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05451420
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Provincial People's Hospital
Collaborators
Xiamen Amoytop Biotech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
inactive hepatitis B virus carriers, HBsAg clearance, peginterferon alpha 2b, Intervention treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
PegIFN α- 2b monotherapy, 180 μg/ week, 68 weeks of treatment, 24 weeks of follow-up after drug withdrawal
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PegIFN α- 2b
Other Intervention Name(s)
pegbin ® 180μg，produced by Xiamen Tebao Bioengineering Co., Ltd.
Intervention Description
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）
Primary Outcome Measure Information:
Title
HBsAg clearance at the end of 68 weeks of treatment
Description
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 Outcome Measure Information:
Title
HBsAg level and the decreasing extent of HBsAg level
Description
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
Title
HBsAg seroconversion rate
Description
To assessment the HBsAg seroconversion rate in different treatment groups
Time Frame
68 weeks of treatment
Other Pre-specified Outcome Measures:
Title
HBsAg clearance and seroconversion rate of PEG IFN based immunoadjuvant combined therapy
Description
To assessment the HBsAg clearance and seroconversion rate of immunoadjuvant combined therapy on 68 weeks' curative effect
Time Frame
baseline，12 weeks, 24 weeks, 44 weeks，56 weeks， 68weeks，80 weeks，92weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Shang
Organizational Affiliation
Henan Provincial People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication
IPD Sharing Time Frame
End of study
IPD Sharing Access Criteria
Editors and reviewers of contributing magazines
Learn more about this trial
Inactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy
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