HBsAg Loss/Seroconversion in Low Replicative Chronic Hepatitis B Virus(HBV) Infection Patients
HBsAg Loss/Seroconversion in Low Replicative Chronic HBV Infection Patients With Low Level HBsAg Treated With Peginterferon Alpha
Study Overview
Detailed Description
Low replicative chronic HBV infection patients with low Level HBsAg were enrolled in the out-patient department of 3rd Affiliated Hospital of Sun Yat-sen University. All of them were HBsAg positive and anti-HBs negative for more than 6 months with HBV DNA<2000 IU/mL and HBsAg levels ≤1000 IU/mL. All patients did not have other liver diseases and contraindications for interferon therapy.
After giving informed consent, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study.
In this study, treatment endpoint was HBsAg loss(<0.05 IU/mL) and anti-HBs positive(>10 milli-International unit(mIU)/mL) defined as seroconversion. Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in case of nonresponse. Treatment was proceeded if HBsAg level continued to decline until HBsAg seroconversion was achieved and the anti-HBs level was above 200 mIU/ml. If the patients were not willing to extend treatment, the therapy was ended at the time of HBsAg loss, or stopped without further decline of HBsAg levels.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510630
- Recruiting
- Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL.
- Hepatitis B surface antibody (HBsAb) negative.
- Hepatitis B e antigen (HBeAg) negative.
- Hepatitis B virus DNA <2000 IU/mL.
- Absence of previous antiviral therapy.
Exclusion Criteria:
- Patients with active alcohol and/or drugs consumption.
- Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
- Patients with other factors causing liver diseases.
- Pregnant and lactating women.
- Patients with concomitant HIV infection or congenital immune deficiency diseases.
- Patients with diabetes, autoimmune diseases.
- Patients with important organ dysfunctions.
- Patients with mental illness.
- Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
- Patients who can't come back to clinic for follow-up on schedule.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pegylated interferon group
Low replicative chronic HBV infection patients with HBsAg <1000 IU/ mL and HBV DNA<2000 IU/mL are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for at most 96 weeks.
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peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.
Other Names:
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No Intervention: Observing Group
Only observing and following up in this group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HBsAg Clearance Rate
Time Frame: 96 weeks
|
Percentage of Participants with HBsAg negative.
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96 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HBsAg Seroconversion Rate
Time Frame: 96 weeks
|
Percentage of Participants with HBsAg negative and anti-HBsAg positive
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96 weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Peginterferon alfa-2a
- Peginterferon alfa-2b
Other Study ID Numbers
- 3rd-SYSU-I-Cure-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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