Status:
COMPLETED
Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
3-80 years
Phase:
PHASE1
Brief Summary
Background: The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance. There ...
Detailed Description
Vaccination schedule: Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) will be administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months or until HBsAg clearance. The dosage will be 20μg in those ...
Eligibility Criteria
Inclusion
- Naïve or treated chronic hepatitis B patients with positive HBsAg and negative HBeAg;
- Quantitative serum HBsAg (qHBsAg) \<2000 IU/ml;
- No HIV co-infection;
- No obvious immunodeficiency (such as renal failure, chemotherapy, radiotherapy, immunosuppressant);
- Aged 3 to 80 years;
Exclusion
- Pregnancy
- Allergic to HBV vaccine or yeast.
- Hepatic decompensation
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01817725
Start Date
March 1 2013
End Date
February 1 2016
Last Update
May 2 2017
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taoyuan Xian, Taiwan, 33305