Chronic Hepatitis B Infection Clinical Trial
Official title:
Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Loads Under Unplanned Intervention
NCT number | NCT04030039 |
Other study ID # | DTXY017 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | December 30, 2020 |
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.
Status | Recruiting |
Enrollment | 420 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | liver disease center, Beijing Ditan Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Ditan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | liver cancer during the 96-week study period in different observation cohorts Incidence | liver cancer during the 96-week study period in different observation cohorts Incidence | 96 weeks | |
Other | Hepatitis episodes 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 | |
Other | cirrhosis decompensation 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 | |
Other | its complications 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 | |
Primary | The incidence of HBsAg disappearance during the 96-week study in different observation cohorts | The incidence of HBsAg disappearance during the 96-week study in different observation cohorts | 96 weeks | |
Secondary | HBV DNA re-yang rate during the 96-week study period in different observation cohorts | HBV DNA re-yang rate and HBeAg re-yang rate during the 96-week study period in different observation cohorts | 96 weeks | |
Secondary | HBeAg re-yang rate during the 96-week study | HBeAg re-yang rate during the 96-week study | 96 weeks |
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