Efficay of Extended Peginterferon Alpha 2a Treatment in HBeAg Negative Chronic Hepatitis B Patients
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ClinicalTrials.gov Identifier: NCT02387684
Recruitment Status : Unknown
Verified August 2016 by Yao Xie, Beijing Ditan Hospital. Recruitment status was: Recruiting
The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV defined as sustained viral response after treatment, however, most patients can't get this target after 48 weeks of interferon treatment, and some patients need extended treatment in clinical practice to enhance the rate of sustained viral response or HBsAg loss occurred during treatment. In this cohort study, the efficacy of extended therapy of interferon in HBeAg negative chronic hepatitis B patients will be evaluated.
Condition or disease
Chronic Hepatitis B
In this cohort study, the HBeAg negative chronic hepatitis B patients would be treated with peginterferon alpha 2a(PEG-IFN a-2a) for 96 week and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during treatment and follow period. Parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies were evaluated by the rate of HBsAg loss during treatment and the rate of sustained viral response after treatment and follow up.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Population in this cohort study was composed of HBeAg negative chronic hepatitis B patients defined as HBsAg positive, HBeAg negative,and detectable HBV DNA load with ALT level ≥41 U/L for more than 6 months.
HBeAg negative chronic hepatitis B patients
Active consumption of alcohol and/or drugs
Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus