Status:
UNKNOWN
The Treatment With HBIG+GM-CSF+HBV Vaccine for Chronic Hepatitis B Patients With HBeAg Seroconversion
Lead Sponsor:
Beijing 302 Hospital
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
The host immunity has been generally recognized as the main factors to determine the outcome of chronic hepatitis B virus (HBV) infection; however, previous studies have shown that HBV-specific T cell...
Detailed Description
The host immunity has been generally recognized as the main factors to determine the outcome of chronic hepatitis B virus (HBV) infection. Previous studies have shown that HBV-specific T cell and B ce...
Eligibility Criteria
Inclusion
- chronic hepatitis B patients with HBeAg seroconversion (eAg negative and eab positive)
- age 18-50, male or female
- HBsAg positive for at least 6 months, quantitative HBsAg \<1000 IU/ml (Abbott Diagnostic, Wiesbaden, Germany)
- HBeAg positive CHB patients who have received NAs (lamivudine, adefovir dipivoxil, entecavir, alone or in combination) treatment and achieved HBeAg seroconversion (HBeAg-, HBeAb+), HBV DNA\<40 IU/ml and ALT normalization and maintained for at least 6 months.
- Urine pregnancy test is negative in gestational age female subjects before enrollment, who can take effective contraceptive measures and agree to contraception during treatment and follow-up period.
- Enrolled subjects should understand and sign the informed consent and comply with the requirement of the research before study.
- Enrolled subjects should agree not to participate in other studies, and not to accept other immunomodulatory therapy during the study. Other treatments such as corticosteroids should be informed timely
Exclusion
- Be allergic to HBIG, GM-CSF and HBV vaccine.
- Coinfected with other virus. Any positive for anti-hepatitis A virus (HAV), anti-hepatitis C virus (HCV), anti-hepatitis D virus (HDV), anti-hepatitis E virus (HEV) and anti-HIV.
- Advanced cirrhosis or Child-Pugh 7 scores or above.
- Autoimmune thrombocytopenic purpura, coronary heart disease, cerebrovascular disease, hypertension, diabetes mellitus, high myopia, history of epilepsy.
- Other causes of liver disease, such as autoimmune liver disease, alcoholic liver disease, nonalcoholic liver disease, drug-induced liver disease and other unknown causes of chronic liver diseases.
- Associated with other serious organic disease, mental illness, including any uncontrolled urinary, respiratory, circulation, nervous, digestive, endocrine, spirit, immune system diseases and tumor.
- Suspected liver cancer or alpha feto protein (AFP) \> 100ng/ml.
- Neutrophil count \< 2.5×109/L, or hemoglobin \< 100g/L, or platelet \< 80×109/L.
- Pregnant or lactating women.
- Allergic constitution, allergy history for blood products, known allergy to experimental drugs.
- Alcohol or drug addiction, drug use history evidence within one year before enrolled in the study.
- Received immunosuppressive or other immune modulators (including thymosin) or systemic cytotoxic drug 6 months before enrolled in the study.
- Incompliance during antiviral therapy.
- Enrolled in other clinical trials at present, and possible to be against the treatment and observation index.
- Unable or unwilling to provide informed consent or fails to comply with the requirements of the study.
- Other serious conditions that may hamper clinical trials.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01878565
Start Date
June 1 2013
End Date
July 1 2015
Last Update
July 24 2013
Active Locations (1)
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1
Beijing 302 Hospital
Beijing, China, 100039