Chronic Hepatitis B Infection
Conditions
Keywords
Chronic hepatitis B, interferon, nucleotide, HBV, HBsAg, HBV DNA
Brief summary
All chronic hepatitis B (CHB) patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg\<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) CHB patients in the immunological control period, without any clinical treatment intervention; 2) After interferon therapy, HBsAg\<100 IU/ml, continued interferon therapy; 3) After interferon therapy, HBsAg\<100 IU/ml, stopped interferon treatment; 4) After interferon therapy, HBsAg\<100 IU/ml, sequential nucleoside analog treatment; 5) After nucleoside analogue treatment, HBsAg\<100 IU/ml, sequential interferon treatment; 6) After treated with nucleoside analogues, HBsAg\<100 IU/ml, continuing the nucleoside analog treatment. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV indicators and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.
Detailed description
This study is a clinical observational cohort study. All chronic hepatitis B patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg\<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) chronic Hepatitis B patients in the immunological control period, without any clinical treatment intervention in this cohort; 2) After interferon therapy, HBsAg\<100 IU/ml, continued interferon therapy in this cohort; 3) After interferon therapy, HBsAg\<100 IU/ml, stopped interferon treatment in this cohort; 4) After interferon therapy, HBsAg\<100 IU/ml, sequential nucleoside analog treatment in this cohort; 5) After nucleoside analogue treatment, HBsAg\<100 IU/ml, sequential interferon treatment in this cohort; 6) After treated with nucleoside analogues, HBsAg\<100 IU/ml, continuing the nucleoside analog treatment in this cohort. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV DNA loads, HBsAg/anti-HBs, HBeAg/anti-HBe and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.
Interventions
DRUGInterferon
chronic hepatitis B patients with interferon therapy
chronic hepatitis B patients with interferon therapy
Sponsors
Beijing Ditan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Inactive carrier status and chronic hepatitis B (CHB) patients with anti-viral therapy (interferon and nucleoside analogues) reaching HBsAg \< 100 IU/ml.
Exclusion criteria
* coinfection with other viruses including HCV, HDV, and HIV; * syphilis antibody positive; * co-exist other liver diseases including alcoholic liver disease, metabolic liver disease, fatty liver, drug induce liver injury, and autoimmune liver disease; * complication of cirrhosis or liver cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of HBsAg disappearance during the 96-week study in different observation cohorts | 96 weeks | The incidence of HBsAg disappearance during the 96-week study in different observation cohorts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBV DNA re-yang rate during the 96-week study period in different observation cohorts | 96 weeks | HBV DNA re-yang rate and HBeAg re-yang rate during the 96-week study period in different observation cohorts |
| HBeAg re-yang rate during the 96-week study | 96 weeks | HBeAg re-yang rate during the 96-week study |
Other
| Measure | Time frame | Description |
|---|---|---|
| liver cancer during the 96-week study period in different observation cohorts Incidence | 96 weeks | liver cancer during the 96-week study period in different observation cohorts Incidence |
| its complications during the 96-week study period in different observation cohorts Incidence | 96 weeks | its complications during the 96-week study period in different observation cohorts Incidence |
| Hepatitis episodes during the 96-week study period in different observation cohorts Incidence | 96 weeks | Hepatitis episodes during the 96-week study period in different observation cohorts Incidence |
| cirrhosis decompensation during the 96-week study period in different observation cohorts Incidence | 96 weeks | cirrhosis decompensation during the 96-week study period in different observation cohorts Incidence |
Countries
China
Contacts
Primary ContactYao Xie, Doctor
Backup ContactMing Hui Li, MD
Outcome results
None listed